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Margetuximab (Margenza) for HER2-Positive Breast Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • November 28, 2022;  (Issue 1664)
The FDA has approved margetuximab-cmkb (Margenza – MacroGenics), a HER2/neu receptor antagonist, for use in combination with chemotherapy for treatment of metastatic human epidermal growth factor receptor...
The FDA has approved margetuximab-cmkb (Margenza – MacroGenics), a HER2/neu receptor antagonist, for use in combination with chemotherapy for treatment of metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2 regimens, at least one of which was for metastatic disease.
Med Lett Drugs Ther. 2022 Nov 28;64(1664):e195-6 | Show Full IntroductionHide Full Introduction

Mobocertinib (Exkivity) for Non-Small Cell Lung Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • November 28, 2022;  (Issue 1664)
Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with...
Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. Mobocertinib is the second drug to become available in the US for this indication; the IV EGFR-MET bispecific antibody amivantamab (Rybrevant) was approved earlier.
Med Lett Drugs Ther. 2022 Nov 28;64(1664):e197-8 | Show Full IntroductionHide Full Introduction

Alpelisib (Vijoice) for PIK3CA-Related Overgrowth Spectrum (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS)...
The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic treatment. Alpelisib is the first drug to be approved in the US for this indication. It was also approved in 2019 as Piqray for use in combination with fulvestrant for treatment of certain types of breast cancer.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e186-7 | Show Full IntroductionHide Full Introduction

Amivantamab (Rybrevant) for Non-Small Cell Lung Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET bispecific antibody, has received accelerated approval from the FDA for IV treatment of locally advanced or metastatic non-small cell lung...
Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET bispecific antibody, has received accelerated approval from the FDA for IV treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. It is the first bispecific antibody to become available in the US for this indication. Accelerated approval of the drug was based on the overall response rate and duration of response.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e184-5 | Show Full IntroductionHide Full Introduction

Idecabtagene Vicleucel (Abecma) for Multiple Myeloma (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
The FDA has approved idecabtagene vicleucel (Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for treatment of relapsed or refractory multiple myeloma...
The FDA has approved idecabtagene vicleucel (Abecma – BMS), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Abecma is an individualized cellular product prepared from the patient’s own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. Ciltacabtagene autoleucel (Carvykti), another CAR T-cell product, is also available for the same indication.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e190-1 | Show Full IntroductionHide Full Introduction

Neratinib (Nerlynx) for Metastatic HER2-Positive Breast Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or...
The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in about 20% of breast cancers. Up to 30% of early-stage, HER2-positive breast cancer cases treated with trastuzumab-based adjuvant therapy recur. Neratinib is the only HER2-directed small molecule approved for treatment of early-stage and metastatic HER2-postive breast cancer.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e192-3 | Show Full IntroductionHide Full Introduction

A New Indication for Axicabtagene Ciloleucel (Yescarta) (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
The FDA recently approved axicabtagene ciloleucel (Yescarta – Kite), a CD19-directed genetically modified cellular product, for treatment of large B-cell lymphoma that is refractory to first-line...
The FDA recently approved axicabtagene ciloleucel (Yescarta – Kite), a CD19-directed genetically modified cellular product, for treatment of large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line treatment. It was previously approved for treatment of relapsed or refractory B-cell lymphoma after ≥2 lines of systemic therapy and for treatment of relapsed or refractory follicular lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e194-5 | Show Full IntroductionHide Full Introduction

Teclistamab-cqyv (Tecvayli) For Multiple Myeloma (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
Teclistamab-cqyv (Tecvayli – Janssen), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory...
Teclistamab-cqyv (Tecvayli – Janssen), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e196-7 | Show Full IntroductionHide Full Introduction

Lurbinectedin (Zepzelca) for Small-Cell Lung Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • November 14, 2022;  (Issue 1663)
The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or...
The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.
Med Lett Drugs Ther. 2022 Nov 14;64(1663):e198-9 | Show Full IntroductionHide Full Introduction

Phosphodiesterase-5 Inhibitors for Alzheimer's Disease?

   
The Medical Letter on Drugs and Therapeutics • October 31, 2022;  (Issue 1662)
A reader asked us to review use of the phosphodiesterase-5 (PDE5) inhibitor sildenafil for treatment of Alzheimer's disease...
A reader asked us to review use of the phosphodiesterase-5 (PDE5) inhibitor sildenafil for treatment of Alzheimer's disease (AD).
Med Lett Drugs Ther. 2022 Oct 31;64(1662):174-5 | Show Full IntroductionHide Full Introduction

In Brief: OTC Azelastine Nasal Spray 0.15% (Astepro Allergy) for Allergic Rhinitis

   
The Medical Letter on Drugs and Therapeutics • October 31, 2022;  (Issue 1662)
The 0.15% nasal spray formulation of the H1- antihistamine azelastine hydrochloride (Astepro Allergy; Children's Astepro Allergy – Bayer) is now available over the counter (OTC) for temporary relief of...
The 0.15% nasal spray formulation of the H1- antihistamine azelastine hydrochloride (Astepro Allergy; Children's Astepro Allergy – Bayer) is now available over the counter (OTC) for temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to allergic rhinitis in adults and children ≥6 years old. It is the first intranasal antihistamine to be approved by the FDA for OTC use. Other drugs that are available OTC for treatment of allergic rhinitis symptoms include oral antihistamines, intranasal corticosteroids, and mast cell stabilizers.
Med Lett Drugs Ther. 2022 Oct 31;64(1662):175-6 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Novavax Vaccine Authorized for Booster Immunization (online only)

   
The Medical Letter on Drugs and Therapeutics • October 31, 2022;  (Issue 1662)
The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary...
The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include its use as a first booster dose in adults who completed a primary series with any COVID-19 vaccine ≥6 months previously and are unable or unwilling to receive a booster dose of a bivalent mRNA vaccine. The Novavax vaccine is not authorized for use in persons who have received a booster dose of any other COVID-19 vaccine.
Med Lett Drugs Ther. 2022 Oct 31;64(1662):e1-2 | Show Full IntroductionHide Full Introduction

Two Vonoprazan Combinations (Voquezna) for H. pylori

   
The Medical Letter on Drugs and Therapeutics • October 31, 2022;  (Issue 1662)
The FDA has approved vonoprazan, a potassium-competitive acid blocker, copackaged with amoxicillin (Voquezna Dual Pak – Phathom) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment...
The FDA has approved vonoprazan, a potassium-competitive acid blocker, copackaged with amoxicillin (Voquezna Dual Pak – Phathom) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults. Vonoprazan is the first potassium-competitive acid blocker to be approved in the US. It has been available in Japan for treatment of various acid-related disorders since 2014. Vonoprazan is not available alone in the US.
Med Lett Drugs Ther. 2022 Oct 31;64(1662):169-72 | Show Full IntroductionHide Full Introduction

Two New Oral Testosterone Products for Hypogonadism

   
The Medical Letter on Drugs and Therapeutics • October 31, 2022;  (Issue 1662)
The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to...
The FDA has approved two new oral formulations of testosterone undecanoate — Kyzatrex (Marius) and Tlando (Antares) — for treatment of males with a deficiency of endogenous testosterone due to conditions such as Klinefelter syndrome, orchiectomy, toxic damage from chemotherapy or alcohol, or pituitary-hypothalamic injury caused by tumors, trauma, or radiation. Jatenzo, another oral testosterone undecanoate formulation, was approved for the same indication in 2019. No testosterone products are approved for treatment of low testosterone levels due solely to aging.
Med Lett Drugs Ther. 2022 Oct 31;64(1662):172-4 | Show Full IntroductionHide Full Introduction

Ruxolitinib Cream (Opzelura) for Nonsegmental Vitiligo

   
The Medical Letter on Drugs and Therapeutics • October 3, 2022;  (Issue 1660)
The 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years...
The 1.5% cream formulation of the Janus kinase (JAK) inhibitor ruxolitinib (Opzelura – Incyte) has been approved by the FDA for topical treatment of nonsegmental vitiligo (NSV) in patients ≥12 years old. Opzelura is the first product to be approved by the FDA for this indication. It was previously approved for treatment of atopic dermatitis.
Med Lett Drugs Ther. 2022 Oct 3;64(1660):158-9 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Bivalent Pfizer and Moderna COVID-19 Vaccines for Booster Immunization

   
The Medical Letter on Drugs and Therapeutics • October 3, 2022;  (Issue 1660)
The FDA has amended its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of bivalent formulations of the...
The FDA has amended its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of bivalent formulations of the products as a single booster dose in persons ≥12 years old (Pfizer) or ≥18 years old (Moderna) whose most recent COVID-19 vaccine dose was a monovalent product given ≥2 months previously as a booster or for completion of a primary series. The bivalent formulations are not authorized for primary immunization. Monovalent Pfizer and Moderna COVID-19 vaccines are no longer authorized for use as booster doses in persons ≥12 years old.
Med Lett Drugs Ther. 2022 Oct 3;64(1660):159-60 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Novavax Vaccine Authorized for Adolescents 12-17 Years Old (online only)

   
The Medical Letter on Drugs and Therapeutics • October 3, 2022;  (Issue 1660)
The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents...
The FDA has expanded its Emergency Use Authorization for the adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax to include use of the vaccine as a two-dose primary series in adolescents 12-17 years old. The vaccine was authorized for primary immunization of adults in July 2022.
Med Lett Drugs Ther. 2022 Oct 3;64(1660):e160 | Show Full IntroductionHide Full Introduction

Baricitinib (Olumiant) for Severe Alopecia Areata

   
The Medical Letter on Drugs and Therapeutics • September 5, 2022;  (Issue 1658)
The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19...
The oral Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly), which was previously approved by the FDA for treatment of moderately to severely active rheumatoid arthritis and treatment of COVID-19 in certain hospitalized adults, has now been approved for treatment of severe alopecia areata in adults. Baricitinib is the first systemic treatment to be approved in the US for this indication.
Med Lett Drugs Ther. 2022 Sep 5;64(1658):139-41 | Show Full IntroductionHide Full Introduction

Nalmefene Returns for Reversal of Opioid Overdose

   
The Medical Letter on Drugs and Therapeutics • September 5, 2022;  (Issue 1658)
The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from...
The FDA has approved a generic injectable formulation of the opioid antagonist nalmefene (Purdue) for the management of known or suspected opioid overdose. Revex, the reference product, was withdrawn from the market in 2008 for commercial reasons.
Med Lett Drugs Ther. 2022 Sep 5;64(1658):141-2 | Show Full IntroductionHide Full Introduction

Upadacitinib (Rinvoq): A Second JAK Inhibitor for Ulcerative Colitis

   
The Medical Letter on Drugs and Therapeutics • September 5, 2022;  (Issue 1658)
The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to...
The FDA has approved the oral Janus kinase (JAK) inhibitor upadacitinib (Rinvoq – Abbvie) for treatment of moderately to severely active ulcerative colitis in adults who have had an inadequate response to or cannot tolerate one or more tumor necrosis factor (TNF) inhibitors. Upadacitinib is the second JAK inhibitor to be approved for this indication; tofacitinib (Xeljanz) was the first. Upadacitinib is also approved for treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ankylosing spondylitis.
Med Lett Drugs Ther. 2022 Sep 5;64(1658):142-4 | Show Full IntroductionHide Full Introduction

Prevention and Treatment of Monkeypox

   
The Medical Letter on Drugs and Therapeutics • September 5, 2022;  (Issue 1658)
An outbreak of monkeypox has recently spread around the globe and across the US. Updated information about the current outbreak is available from the...
An outbreak of monkeypox has recently spread around the globe and across the US. Updated information about the current outbreak is available from the CDC.
Med Lett Drugs Ther. 2022 Sep 5;64(1658):137-9 | Show Full IntroductionHide Full Introduction

COVID-19 Update: FDA Authorizes Novavax COVID-19 Vaccine

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent...
The FDA has issued an Emergency Use Authorization (EUA) for an adjuvanted protein subunit COVID-19 vaccine manufactured by Novavax. The vaccine is indicated for use as a two-dose primary series to prevent COVID-19 in adults; it is not authorized for use in children or as a booster dose. Three other COVID-19 vaccines are available in the US for primary immunization of adults; the mRNA vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) are FDA-licensed for this indication, and the adenovirus-based vaccine manufactured by Johnson & Johnson (Janssen) is available under an EUA for use in adults who are unable or unwilling to receive another COVID-19 vaccine.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):121-2 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6...
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6 months in patients who require ongoing protection against COVID-19. Evusheld is authorized for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e122-3 | Show Full IntroductionHide Full Introduction

Tapinarof Cream (Vtama) for Psoriasis

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to...
The FDA has approved Vtama (Dermavant), a 1% cream formulation of the aryl hydrocarbon receptor (AhR) agonist tapinarof, for treatment of adults with plaque psoriasis. It is the first AhR agonist to be approved by the FDA.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):122-4 | Show Full IntroductionHide Full Introduction

Oteseconazole (Vivjoa) for Recurrent Vulvovaginal Candidiasis

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole...
The FDA has approved oteseconazole (Vivjoa – Mycovia), a new oral azole antifungal, to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC. Oteseconazole is the first drug to be approved in the US specifically for treatment of RVVC.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):124-6 | Show Full IntroductionHide Full Introduction

Lumateperone (Caplyta) for Bipolar Depression

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use...
The oral second-generation antipsychotic drug lumateperone (Caplyta – Intra-Cellular Therapies), which was approved by the FDA in 2020 for treatment of schizophrenia, is now approved for use as monotherapy or as an adjunct to lithium or valproate for treatment of depressive episodes associated with bipolar I or II disorder in adults.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):126-8 | Show Full IntroductionHide Full Introduction

A Donepezil Patch (Adlarity) for Alzheimer's Disease (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD)...
A once-weekly transdermal formulation of the acetylcholinesterase inhibitor donepezil (Adlarity – Corium) has been approved by the FDA for treatment of mild, moderate, and severe Alzheimer's disease (AD) dementia. Donepezil is the second acetylcholinesterase inhibitor to become available in a transdermal formulation; transdermal rivastigmine (Exelon Patch), which is applied once daily, has been available for years for the same indication. Donepezil is also available in oral formulations (Aricept, and generics) for treatment of AD dementia.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e128-9 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Prescription of Paxlovid by Pharmacists (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed...
The FDA has amended its Emergency Use Authorization (EUA) for Paxlovid (Pfizer), the investigational oral antiviral drug nirmatrelvir copackaged with oral ritonavir, to allow for it to be prescribed by licensed pharmacists in certain situations. Paxlovid is authorized for oral treatment of mild to moderate COVID-19 in high-risk outpatients ≥12 years old who weigh at least 40 kg. NIH guidelines list it as the treatment of choice for COVID-19 in high-risk adult outpatients.
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e124 | Show Full IntroductionHide Full Introduction

Tezepelumab (Tezspire) for Severe Asthma

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma...
Tezepelumab-ekko (Tezspire – AstraZeneca/Amgen), a subcutaneously administered thymic stromal lymphopoietin (TSLP) blocker, has been approved by the FDA for add-on maintenance treatment of severe asthma in patients ≥12 years old. It is the first TSLP blocker to become available in the US and the first biologic drug to be approved for treatment of severe asthma without phenotypic or biomarker limitations.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):25-6 | Show Full IntroductionHide Full Introduction

Remimazolam (Byfavo) for Short-Term Procedural Sedation

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes'...
The FDA has approved remimazolam (Byfavo – Acacia Pharma), an ultra-short-acting IV benzodiazepine, for induction and maintenance of sedation in adults undergoing procedures of up to 30 minutes' duration.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):26-8 | Show Full IntroductionHide Full Introduction

Odevixibat (Bylvay) for Progressive Familial Intrahepatic Cholestasis-Associated Pruritus

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial...
Odevixibat (Bylvay – Albireo), an oral ileal bile acid transporter (IBAT) inhibitor, has been approved by the FDA for treatment of pruritus in patients ≥3 months old with progressive familial intrahepatic cholestasis (PFIC). It is the first drug to be approved in the US for this indication.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):28 | Show Full IntroductionHide Full Introduction

Cabotegravir (Apretude) for HIV-1 Pre-Exposure Prophylaxis

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually...
The FDA has approved Apretude (ViiV Healthcare), an IM extended-release (ER) formulation of the integrase strand transfer inhibitor (INSTI) cabotegravir, for use every 2 months to prevent sexually acquired HIV-1 infection in at-risk adolescents and adults. Apretude is the first ER formulation to be FDA-approved for pre-exposure prophylaxis (PrEP) of HIV-1 infection.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):29-31 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • February 21, 2022;  (Issue 1644)
The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to...
The IV antiviral drug remdesivir (Veklury – Gilead) has been available for treatment of COVID-19 in hospitalized patients since 2020. Now, the FDA has approved remdesivir for treatment of mild to moderate COVID-19 in outpatients ≥12 years old who weigh ≥40 kg and are at high risk for progression to severe disease, including hospitalization or death; they also issued an Emergency Use Authorization (EUA) allowing its use in any other high-risk outpatient who weighs ≥3.5 kg.
Med Lett Drugs Ther. 2022 Feb 21;64(1644):31-2 | Show Full IntroductionHide Full Introduction

Booster Doses of COVID-19 Vaccines

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based...
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA-based COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) and the adenovirus-based vaccine manufactured by Johnson & Johnson/Janssen to include administration of a booster dose in select populations after primary immunization with either the same COVID-19 vaccine or a different one.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):186-8 | Show Full IntroductionHide Full Introduction

Two New Pneumococcal Vaccines - Prevnar 20 and Vaxneuvance

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes...
The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes. Two other pneumococcal vaccines are available in the US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate vaccine licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23; Merck), a 23-valent pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years old.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):188-90 | Show Full IntroductionHide Full Introduction

Olanzapine/Samidorphan (Lybalvi) for Schizophrenia and Bipolar Disorder

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults...
The FDA has approved Lybalvi (Alkermes), a fixed-dose combination of the second-generation antipsychotic olanzapine (Zyprexa, and generics) and samidorphan, a new opioid antagonist, for treatment of adults with schizophrenia or with manic or mixed episodes of bipolar I disorder. The addition of samidorphan is intended to mitigate the weight gain that occurs with olanzapine. This is the first FDA approval for samidorphan.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):191-2 | Show Full IntroductionHide Full Introduction

In Brief: Pfizer/BioNTech COVID-19 Vaccine Authorized for Children 5-11 Years Old

   
The Medical Letter on Drugs and Therapeutics • November 29, 2021;  (Issue 1638)
The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children...
The FDA has issued an Emergency Use Authorization (EUA) for a lower-strength (10 mcg/0.2 mL) formulation of the mRNA-based COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) for use in children 5-11 years old. The original formulation of (Comirnaty) (30 mcg/0.3 mL) is FDA-licensed for use in persons ≥16 years old and available under an EUA for use in adolescents 12-15 years old.
Med Lett Drugs Ther. 2021 Nov 29;63(1638):185 | Show Full IntroductionHide Full Introduction

In Brief: Dapagliflozin (Farxiga) for Chronic Kidney Disease

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of...
The sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Farxiga – AstraZeneca) has been approved by the FDA for treatment of adults with chronic kidney disease (CKD) at risk of progression (not defined in the label). Dapagliflozin is the first SGLT2 inhibitor to be approved in the US for treatment of CKD.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):115 | Show Full IntroductionHide Full Introduction

Sunscreens

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and...
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):115-20 | Show Full IntroductionHide Full Introduction

Addendum: Aducanumab (Aduhelm) for Alzheimer's Disease

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with...
In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):120 | Show Full IntroductionHide Full Introduction

In Brief: Johnson & Johnson COVID-19 Vaccine Suspended (online only)

   
The Medical Letter on Drugs and Therapeutics • May 3, 2021;  (Issue 1623)
On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST)...
On April 13, 2021, the FDA and CDC advised suspending use of the Johnson & Johnson adenovirus-based COVID-19 vaccine while the agencies investigate 6 cases of cerebral venous sinus thrombosis (CVST) and thrombocytopenia that occurred following administration of the vaccine. In an April 14 emergency meeting, the Advisory Committee on Immunization Practices (ACIP) recommended continuing the suspension until more data become available. About 7 million people in the US have received the Johnson & Johnson vaccine.
Med Lett Drugs Ther. 2021 May 3;63(1623):e1 | Show Full IntroductionHide Full Introduction