The Medical Letter - 2023
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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...