The Medical Letter - 2021
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April 19, 2021 (Issue 1622)
- Drugs for Allergic Rhinitis and Allergic Conjunctivitis
The choice of drugs for treatment of allergic rhinitis depends on the severity of symptoms and whether they are are intermittent or persistent (see Table 1). - Comparison Table: Some Oral Drugs for Allergic Rhinitis (online only)
View the Comparison Table: Some Oral Drugs for Allergic Rhinitis - Comparison Table: Some Nasal Sprays for Allergic Rhinitis (online only)
View the Comparison Table: Some Nasal Sprays for Allergic Rhinitis
April 5, 2021 (Issue 1621)
- An EUA for Bamlanivimab and Etesevimab for COVID-19
The FDA has issued an Emergency Use Authorization (EUA) for Lilly's investigational monoclonal antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) to be administered together for... - Oriahnn for Fibroid-Associated Heavy Menstrual Bleeding
Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate... - Semaglutide (Ozempic) for Weight Loss
In recently published clinical trials, once-weekly subcutaneous injection of the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk), which is... - Low-Dose Colchicine for Coronary Artery Disease
The centuries-old anti-inflammatory drug colchicine (Colcrys, and others) is FDA-approved for prophylaxis and treatment of gout flares and for treatment of familial Mediterranean fever. It... - In Brief: Hypertension with Erenumab (Aimovig)
The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of... - Ripretinib (Qinlock) for GIST (online only)
The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously... - COVID-19 Vaccine Comparison Chart (online only)
View the COVID-19 Vaccine Comparison Chart
March 22, 2021 (Issue 1620)
- FDA Authorizes Johnson & Johnson COVID-19 Vaccine
On February 27, 2021, the FDA issued an Emergency Use Authorization (EUA) for the Johnson & Johnson adenovirus-based vaccine for prevention of COVID-19 in persons ≥18 years old. It is the third... - Drugs for Multiple Sclerosis
Most patients with multiple sclerosis (MS) present with the relapsing-remitting form of the disease. Pharmacologic treatment usually includes a disease-modifying drug, corticosteroids for... - Stiripentol (Diacomit) for Dravet Syndrome (online only)
The FDA has approved stiripentol (Diacomit – Biocodex) for treatment of seizures in patients ≥2 years old with Dravet syndrome who are also taking clobazam (Onfi). Stiripentol, which...
March 8, 2021 (Issue 1619)
- Sodium Sulfate-Based Tablets (Sutab) for Colonoscopy Preparation
The FDA has approved an oral tablet formulation of sodium sulfate, magnesium sulfate, and potassium chloride (Sutab – Braintree) for colon cleansing prior to colonoscopy in adults. A... - Vericiguat (Verquvo) for Heart Failure
The FDA has approved vericiguat (Verquvo – Merck), an oral soluble guanylate cyclase (sGC) stimulator, to reduce the risk of hospitalization for heart failure and cardiovascular (CV)... - Oliceridine (Olinvyk) - A New Opioid for Severe Pain
Oliceridine (Olinvyk - Trevena), an IV opioid agonist, has been approved by the FDA for management of acute pain severe enough to require an opioid and for which alternative treatment... - Ashwagandha Supplements
Ashwagandha is an herb extracted from the roots of an evergreen shrub (Withania somnifera) found in India that has been used as a "tonic" for centuries. No specific constituent has been... - Comparison Table: Some Drugs for HFrEF (online only)
View the Comparison Table: Some Drugs for HFrEF - Lanadelumab (Takhzyro) for Prevention of Hereditary Angioedema (online only)
The FDA has approved lanadelumab-flyo (Takhzyro – Takeda), a subcutaneously-administered plasma kallikrein inhibitor, for prevention of hereditary angioedema (HAE) attacks in adults and... - In Brief: Phesgo - A Fixed-Dose Combination for HER-2 Positive Breast Cancer (online only)
The FDA has approved a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase (Phesgo – Genentech) for use in combination with chemotherapy for neoadjuvant (preoperative)...
February 22, 2021 (Issue 1618)
- Drugs for Parkinson's Disease
The motor symptoms of Parkinson's disease (PD) are caused primarily by degeneration of dopaminergic neurons in the substantia nigra. The nonmotor symptoms of the disease are thought to be caused... - Comparison Table: Drugs for Parkinson's Disease (online only)
View the Comparison Table: Drugs for Parkinson's Disease
February 8, 2021 (Issue 1617)
- Twirla - A New Contraceptive Patch
The FDA has approved Twirla (Agile Therapeutics), a transdermal contraceptive patch containing the estrogen ethinyl estradiol and the progestin levonorgestrel, for use in women with a BMI - Pitolisant (Wakix) for Narcolepsy
The FDA has approved pitolisant (Wakix – Harmony), a histamine-3 (H3)-receptor antagonist/inverse agonist, for treatment of excessive daytime sleepiness (EDS) or cataplexy in... - Osilodrostat (Isturisa) for Cushing's Disease
The FDA has approved osilodrostat (Isturisa – Recordati), a cortisol synthesis inhibitor, for oral treatment of adults with Cushing's disease when surgical resection of the pituitary... - Avapritinib (Ayvakit) for GIST
The FDA has approved the oral tyrosine kinase inhibitor avapritinib (Ayvakit – Blueprint Medicines) for treatment of unresectable or metastatic gastrointestinal stromal tumors (GISTs)... - Sacituzumab Govitecan (Trodelvy) for Metastatic Triple-Negative Breast Cancer (online only)
The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for...
January 25, 2021 (Issue 1616)
- FDA Authorizes Moderna COVID-19 Vaccine
On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech... - Antibacterial Drugs for Community-Acquired Pneumonia
Treatment of community-acquired pneumonia (CAP) is usually empiric, with selected antibiotic regimens directed against some of the most common causative pathogens. Recommended empiric regimens... - In Brief: Semglee - A New Insulin Glargine for Diabetes
The FDA has approved Semglee (Mylan), an insulin glargine product similar to Lantus, for treatment of type 1 diabetes in children and adults and type 2 diabetes in adults.... - Encorafenib (Braftovi) for Metastatic Colorectal Cancer
The FDA has approved the oral kinase inhibitor encorafenib (Braftovi – Pfizer), in combination with the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux), for...
January 11, 2021 (Issue 1615)
- FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine
The FDA has issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech mRNA-based vaccine for prevention of COVID-19 in persons ≥16 years old. - Baloxavir (Xofluza) for Post-Exposure Prophylaxis of Influenza
The oral polymerase acidic endonuclease inhibitor baloxavir marboxil (Xofluza — Genentech) is now FDAapproved for post-exposure prophylaxis of influenza in patients ≥12 years old.... - Opicapone (Ongentys) - A COMT Inhibitor for Parkinson's Disease
The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in... - Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis
The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D2) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and... - In Brief: An Asenapine Patch (Secuado) for Schizophrenia
A transdermal formulation of the second-generation (atypical) antipsychotic asenapine (Secuado – Noven) has been approved by the FDA for once-daily treatment of schizophrenia in adults....