The Medical Letter - 2023
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June 12, 2023 (Issue 1678)
- Drugs for Migraine An oral nonopioid analgesic is often sufficient for acute treatment of mild to moderate migraine pain without severe nausea or vomiting. A triptan is the drug of choice for treatment of moderate to...
- Comparison Table: Triptans for Migraine (online only) View the Comparison Table: Triptans for Migraine
- Comparison Table: Some Drugs for Migraine Prevention in Adults (online only) View the Comparison Table: Some Drugs for Migraine Prevention in Adults
May 29, 2023 (Issue 1677)
- Live Fecal Microbiota Oral Capsules (Vowst) for Prevention of CDI Recurrence The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live fecal microbiota spores, for prevention of additional recurrences of Clostridioides difficile infection...
- Eflapegrastim (Rolvedon) for Prevention of Chemotherapy-Induced Febrile Neutropenia Eflapegrastim-xnst ((Rolvedon) [Spectrum]; previously called Rolontis), a granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG4, has been approved by the FDA to...
- Cariprazine (Vraylar) for Adjunctive Treatment of Depression The FDA has approved the second-generation antipsychotic drug cariprazine (Vraylar — Abbvie) for adjunctive treatment of major depressive disorder (MDD) in adults. Cariprazine was previously approved for...
- COVID-19 Update: An EUA for Vilobelimab (Gohibic) for COVID-19 The investigational anti-complement component 5a (C5a) antibody vilobelimab (Gohibic – InflaRx) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of hospitalized adults with...
- COVID-19 Update: Metformin to Prevent Long Covid? Results from a double-blind trial suggest that off-label use of the oral antihyperglycemic drug metformin in patients with COVID-19 may decrease the risk of post-acute sequelae of SARS-CoV-2...
- Polatuzumab vedotin (Polivy) for Lymphoma (online only) Polatuzumab vedotin-piiq (Polivy – Genentech), a CD79b-directed antibody and microtubule inhibitor conjugate, has been approved by the FDA for use in combination with rituximab,...
- Enfortumab Vedotin (Padcev) for Urothelial Cancer (online only) Enfortumab vedotin-ejfv (Padcev – Astellas), a nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval from the FDA for use with the immune checkpoint inhibitor...
- Omidubicel (Omisirge) for Neutrophil Recovery Following Myeloablative Conditioning Therapy (online only) The FDA has approved omidubicel-onlv (Omisirge – Gamida Cell), a nicotinamide-modified, allogeneic hematopoietic progenitor cell therapy derived from cord blood, to reduce the time to neutrophil...
May 15, 2023 (Issue 1676)
- Choice of Contraceptives Intrauterine devices (IUDs) and the etonogestrel implant are the most effective reversible contraceptive methods available. Hormonal oral contraceptives, patches, rings, and injectables are also effective...
May 1, 2023 (Issue 1675)
- Vibrant – An Oral Vibrating Capsule for Chronic Idiopathic Constipation The Vibrant orally administered vibrating capsule (Vibrant Gastro), an FDA-cleared medical device, is now available by prescription for treatment of adults with chronic idiopathic constipation (CIC) who...
- Altuviiio – A Longer-Acting Factor VIII Product for Hemophilia A The FDA has approved Altuviiio (Sanofi), a von Willebrand Factor (VWF)-independent, recombinant factor VIII concentrate, for routine prophylaxis, on-demand treatment to control bleeding episodes,...
- Lenacapavir (Sunlenca) for Multidrug-Resistant HIV The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Sunlenca – Gilead) for use with other antiretroviral drugs to treat multidrug-resistant HIV-1...
- Cyclosporine Ophthalmic Emulsion (Verkazia) for Vernal Keratoconjunctivitis The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to...
- In Brief: Over-the-Counter Narcan Nasal Spray The FDA has approved the over-the-counter (OTC) sale of Narcan (Emergent), a nasal spray that delivers 4 mg of the opioid antagonist naloxone. Narcan nasal spray has been available by prescription since...
- Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines (online only) View the Vaccination Recommendations for Bivalent mRNA COVID-19 Vaccines
- Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines (online only) View the Dosing Recommendations for Novavax and Johnson & Johnson COVID-19 Vaccines
April 17, 2023 (Issue 1674)
- Treatment of Common Respiratory Tract Infections Most respiratory tract infections are caused by viruses. Bacterial respiratory tract infections are usually treated empirically with antibiotic therapy that targets the most probable causative...
- In Brief: Cardiovascular Outcomes with Bempedoic Acid (Nexletol) Since our initial review of the oral lipid-lowering adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid (Nexletol – Esperion) in 2020, cardiovascular outcomes data in...
- COVID-19 Update: Pfizer Bivalent Vaccine Booster Dose for Children 6 Months to 4 Years Old The FDA has expanded its Emergency Use Authorization (EUA) for the COVID-19 vaccine manufactured by Pfizer/BioNTech (Comirnaty) to permit use of the bivalent formulation (containing mRNA from the original...
- Capmatinib (Tabrecta) for NSCLC (online only) The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation...
- Cemiplimab (Libtayo) for NSCLC (online only) The FDA has approved cemiplimab-rwlc (Libtayo – Regeneron), an immune checkpoint inhibitor, for use in combination with platinum-based chemotherapy for first-line treatment of locally advanced or...
- Futibatinib (Lytgobi) for Cholangiocarcinoma (online only) The oral kinase inhibitor futibatinib (Lytgobi – Taiho) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or...
- In Brief: A New Indication for Pemigatinib (Pemazyre) (online only) The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor...
- In Brief: Retifanlimab (Zynyz) for Merkel Cell Carcinoma (online only) Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel...
- In Brief: Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Glioma (online only) The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have been approved by the FDA for use together for a sixth indication: treatment of low-grade glioma...
- In Brief: Olaparib (Lynparza) for High-Risk Early Breast Cancer (online only) The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has been approved by the FDA for adjuvant treatment of adults with deleterious or suspected deleterious...
April 3, 2023 (Issue 1673)
- Pegcetacoplan (Syfovre) for Geographic Atrophy in Age-Related Macular Degeneration The FDA has approved the complement C3 inhibitor pegcetacoplan (Syfovre – Apellis) for treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Given as a series...
- Three Drugs for Atopic Dermatitis (Adbry, Cibinqo, and Rinvoq) The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq –...
- In Brief: Rezvoglar - Another Insulin Glargine Product Interchangeable with Lantus Insulin glargine-aglr (Rezvoglar – Lilly), which was approved by the FDA as a biosimilar to the reference product Lantus in 2021 and received interchangeability status with Lantus in 2022, will become...
- Atezolizumab (Tecentriq) for Alveolar Soft Part Sarcoma (online only) Atezolizumab (Tecentriq – Genentech), an immune checkpoint inhibitor, has been approved by the FDA for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients ≥2 years old....
- Olutasidenib (Rezlidhia) for Acute Myeloid Leukemia (online only) Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a...
- In Brief: Fam-trastuzumab deruxtecan (Enhertu) for Breast Cancer (online only) Fam-trastuzumab deruxtecan-nxki (Enhertu – Daiichi Sankyo/AstraZeneca), which received accelerated approval by the FDA in 2019 for treatment of HER2-positive breast cancer based on its rate and duration of...
- In Brief: A New Indication for Abemaciclib (Verzenio) (online only) The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly) has been approved by the FDA for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for...
- Dostarlimab (Jemperli) for Endometrial Cancer (online only) The FDA has granted regular approval to dostarlimabgxly (Jemperli – GSK), an immune checkpoint inhibitor, for treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced...
March 20, 2023 (Issue 1672)
- Drugs for Overactive Bladder In overactive bladder, involuntary bladder contractions due to detrusor overactivity result in urinary urgency, frequency, nocturia, and incontinence. The prevalence of the disorder increases with...
- A Dexamethasone Ophthalmic Insert (Dextenza) for Allergic Conjunctivitis The FDA has approved Dextenza (Ocular Therapeutix), a dexamethasone ophthalmic insert, for treatment of ocular itching associated with allergic conjunctivitis. Dextenza was approved earlier for treatment of...
- Terlipressin (Terlivaz) for Hepatorenal Syndrome The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid...
- In Brief: Off-Label Amitriptyline for Insomnia In our article on Drugs for Chronic Insomnia, we said there is little evidence that antidepressants such as trazodone, mirtazapine, or amitriptyline are effective in treating insomnia not associated with...
March 6, 2023 (Issue 1671)
- Antiviral Drugs for COVID-19 in Vaccinated Outpatients Three products are currently available in the US for treatment of high-risk,1 nonhospitalized adults with mild to moderate COVID-19: oral ritonavir-boosted nirmatrelvir (Paxlovid), IV remdesivir (Veklury),...
- Live Fecal Microbiota (Rebyota) for Prevention of CDI Recurrence The FDA has approved Rebyota (Ferring), a rectally-administered, live fecal microbiota suspension, for prevention of additional recurrences of Clostridioides difficile infection (CDI) following antibiotic...
- Ublituximab (Briumvi) for Relapsing Multiple Sclerosis The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with relapsing forms of multiple sclerosis (MS),...
- Elacestrant (Orserdu) for Advanced or Metastatic Breast Cancer The FDA has approved elacestrant (Orserdu – Stemline), an oral estrogen receptor antagonist, for treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2...
- In Brief: Adstiladrin – A Gene Therapy for Bladder Cancer (online only) Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin...
- Mosunetuzumab (Lunsumio) for Follicular Lymphoma (online only) Mosunetuzumab-axgb (Lunsumio – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for treatment of relapsed or refractory follicular lymphoma in...
- In Brief: A New Breast Cancer Indication for Sacituzumab Govitecan (Trodelvy) (online only) Sacituzumab govitecan-hziy (Trodelvy – Gilead) has been approved for treatment of unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor...
February 20, 2023 (Issue 1670)
- Drugs for Hypothyroidism Primary hypothyroidism is usually the result of Hashimoto's (autoimmune) thyroiditis, thyroidectomy, or radioactive iodine therapy. Treatment of hypothyroidism with replacement doses of thyroid hormone is...
- Deucravacitinib (Sotyktu) for Plaque Psoriasis The FDA has approved deucravacitinib (Sotyktu – BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for once-daily treatment of moderate to severe plaque psoriasis in adults who are candidates for...
- In Brief: Expanded Access to Mifepristone First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies...
- In Brief: Semaglutide (Wegovy) for Weight Loss in Children The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy), which was approved by the FDA in 2021 for chronic weight management in adults, has now been approved for chronic weight...
- In Brief: Zanubrutinib (Brukinsa) for CLL or SLL (online only) The Bruton's tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa), which was previously approved by the FDA for treatment of mantle cell lymphoma, Waldenström's macroglobulinemia, and relapsed or...
- Pirtobrutinib (Jaypirca): A Fourth Bruton's Tyrosine Kinase Inhibitor for Mantle Cell Lymphoma (online only) The Bruton's tyrosine kinase (BTK) inhibitor pirtobrutinib (Jaypirca – Lilly) has received accelerated approval from the FDA for treatment of relapsed or refractory mantle cell lymphoma (MCL) in adults...
- In Brief: A Second Indication for Tucatinib (Tukysa) (online only) The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type...
February 6, 2023 (Issue 1669)
- Lecanemab (Leqembi) for Alzheimer's Disease Lecanemab-irmb (Leqembi – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The label states that...
- Dupilumab (Dupixent) for Eosinophilic Esophagitis and Prurigo Nodularis The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for treatment of eosinophilic esophagitis (EoE) in patients ≥12...
- Epsolay - A Benzoyl Peroxide Cream for Rosacea Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be...
- Transdermal Dextroamphetamine (Xelstrym) for ADHD The FDA has approved a dextroamphetamine transdermal patch (Xelstrym – Noven) for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old. Xelstrym is the...
- COVID-19 Update: Evusheld Unlikely to Neutralize XBB.1.5 Omicron Variant (online only) The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2....
- In Brief: A New Indication for Dabrafenib (Tafinlar) and Trametinib (Mekinist) Combination Therapy (online only) The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of...
- Table: Inhibitors and Inducers of CYP Enzymes, P-Glycoprotein, and Other Transporters (online only) View the Inhibitors and Inducers of CYP Enzymes, P-Glycoprotein, and Other Transporters tables
- Tremelimumab (Imjudo) for Metastatic NSCLC (online only) The FDA has approved tremelimumab-actl (Imjudo – AstraZeneca), a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody, for use in combination with the programmed death-ligand 1 (PD-L1)...
January 23, 2023 (Issue 1668)
- Hemgenix - A Gene Therapy for Hemophilia B Etranacogene dezaparvovec-drlb (Hemgenix – CSL Behring), an adeno-associated virus vector-based gene therapy, has been approved by the FDA for treatment of hemophilia B in adults who currently receive...
- Topical Roflumilast (Zoryve) for Plaque Psoriasis The FDA has approved a 0.3% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of plaque psoriasis in patients ≥12 years old. Roflumilast...
- Olopatadine/Mometasone (Ryaltris) for Allergic Rhinitis The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate...
- In Brief: Furoscix - A Subcutaneous Furosemide Infusor for Heart Failure The FDA has approved Furoscix (scPharmaceuticals), a subcutaneous formulation of the loop diuretic furosemide administered via a single-use, on-body infusor, for treatment of congestion due to...
- In Brief: Finerenone (Kerendia) for Diabetic Kidney Disease Recently published guidelines from the American Diabetes Association (ADA) and the Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group recommend addition of the oral...
- Adagrasib (Krazati) for NSCLC (online only) Adagrasib (Krazati – Mirati Therapeutics), a RAS GTPase family inhibitor, has received accelerated approval from the FDA for oral treatment of KRAS G12C-mutated locally advanced or metastatic...
- Opdualag for Metastatic Melanoma (online only) Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation...
January 9, 2023 (Issue 1667)
- Drugs for Chronic Insomnia Cognitive behavioral therapy for insomnia (CBT-I) is recommended for initial treatment of chronic insomnia. CBT-I includes stimulus control, sleep education and hygiene, sleep restriction, relaxation...
- Expanded Table: Some Oral Drugs for Chronic Insomnia (online only) View the Expanded Table: Some Oral Drugs for Chronic Insomnia
- Teplizumab (Tzield) to Delay Onset of Type 1 Diabetes Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type...
- COVID-19 Update: Tocilizumab (Actemra) FDA-Approved for Treatment of COVID-19 (online only) The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid...