The Medical Letter - 2025
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April 14, 2025 (Issue 1726)
- Penmenvy — A Second Pentavalent Meningococcal Vaccine The FDA has licensed the pentavalent vaccine Penmenvy (GSK) for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W, or Y (MenABCWY) in persons 10-25 years...
- Benzgalantamine (Zunveyl) for Alzheimer's Disease The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate-...
- Palopegteriparatide (Yorvipath) for Hypoparathyroidism Palopegteriparatide (Yorvipath – Ascendis), a parathyroid hormone (PTH) 1-34 analog, has been approved by the FDA for treatment of hypoparathyroidism in adults. The parathyroid hormone analog...
- In Brief: Label Changes for Testosterone Products The FDA has required changes in the labels of all testosterone products to reflect new data on their cardiovascular effects. The updated labels will no longer include a boxed warning about an increased...
- In Brief: New Labeling for Once-Monthly Subcutaneous Buprenorphine (Sublocade) The FDA has approved changes to the labeling of Sublocade (Indivior), an extended-release formulation of the partial opioid agonist buprenorphine, to permit faster initiation and use of alternative...
- In Brief: Once-Monthly Lecanemab (Leqembi) for Alzheimer's Disease The amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi – Eisai/Biogen) has now been approved by the FDA for once-monthly use for treatment of Alzheimer's disease (AD) in patients with mild...
- Mirdametinib (Gomekli) for Neurofibromatosis Type 1 (online only) Mirdametinib (Gomekli – SpringWorks Therapeutics), an oral kinase inhibitor, has been approved by the FDA for treatment of neurofibromatosis type 1 (NF1) in patients ≥2 years old who have symptomatic...
- Vimseltinib (Romvimza) for Tenosynovial Giant Cell Tumor (online only) Vimseltinib (Romvimza – Deciphera), an oral kinase inhibitor, has been approved by the FDA for treatment of symptomatic tenosynovial giant cell tumor in adults for whom surgical resection would cause...
March 31, 2025 (Issue 1725)
- Treatment of Allergic Rhinitis and Allergic Conjunctivitis Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they 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 Seasonal Allergic Rhinitis (online only) View the Comparison Table: Some Nasal Sprays for Seasonal Allergic Rhinitis
- Correction In our recent article on the combination of vanzacaftor, tezacaftor, and deutivacaftor (Alyftrek) for cystic fibrosis (Med Lett Drugs Ther 2025; 67:41), Table 3 misstated the formulations and dosage of...
March 17, 2025 (Issue 1724)
- Vanzacaftor, Tezacaftor, and Deutivacaftor (Alyftrek) for Cystic Fibrosis The FDA has approved Alyftrek (Vertex), an oral fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators vanzacaftor, tezacaftor, and deutivacaftor, for once-daily...
- In Brief: Azmiro — A Single-Dose Injectable Formulation of Testosterone Cypionate The FDA has approved Azmiro (Azurity), the first injectable formulation of testosterone cypionate to become available in single-dose vials and prefilled syringes for treatment of males with...
- Acoramidis (Attruby) for Transthyretin Amyloid Cardiomyopathy The FDA has approved acoramidis (Attruby – BridgeBio), an oral transthyretin stabilizer, to reduce cardiovascular-related hospitalization and cardiovascular death in adults with wild-type or...
- Guselkumab (Tremfya) for Ulcerative Colitis The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved...
March 3, 2025 (Issue 1723)
- Suzetrigine (Journavx) — A Sodium Channel Blocker for Acute Pain The FDA has approved suzetrigine (Journavx – Vertex), a selective sodium channel blocker, for oral treatment of moderate to severe acute pain in adults. Suzetrigine is the first sodium channel blocker to...
- Drugs for Dry Eye Disease Disruption of tear-film homeostasis (altered composition, reduced production, rapid evaporation) and resulting ocular surface inflammation cause the discomfort and blurred vision of dry eye disease. Many...
- Tapinarof Cream (Vtama) for Atopic Dermatitis Tapinarof 1% cream (Vtama – Dermavant), an aryl hydrocarbon receptor (AhR) agonist, has been approved by the FDA for topical treatment of atopic dermatitis in patients ≥2 years old. Tapinarof is...
- A Renal Indication for Semaglutide (Ozempic) The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk) has been approved by the FDA to reduce the risk of sustained eGFR decline, end-stage kidney disease,...
- Datopotamab Deruxtecan (Datroway) for Advanced Breast Cancer (online only) The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of...
- Olezarsen (Tryngolza) for Familial Chylomicronemia Syndrome (online only) Olezarsen (Tryngolza – Ionis), an apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide, has been approved by the FDA to reduce triglyceride levels in adults with familial chylomicronemia...
- Vaccination Recommendations for Updated 2024-2025 COVID-19 Vaccines (online only) View the Vaccination Recommendations for Updated 2024-2025 COVID-19 Vaccines
February 17, 2025 (Issue 1722)
- Nemolizumab (Nemluvio) for Atopic Dermatitis Nemolizumab (Nemluvio – Galderma), a subcutaneously injected interleukin-31 (IL-31) receptor antagonist, has been approved by the FDA for use in combination with topical corticosteroids and/or calcineurin...
- Vadadustat (Vafseo) for Anemia of Chronic Kidney Disease The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who...
- Tirzepatide (Zepbound) for Obstructive Sleep Apnea The injectable glucose-dependent insulinotropic polypeptide (GIP)/glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide (Zepbound) has been approved by the FDA for treatment of moderate to severe...
- In Brief: New Warning for the RSV Vaccines Arexvy and Abrysvo The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS)...
- In Brief: Anaphylaxis with Glatiramer Acetate The FDA has required a new boxed warning in the label of the subcutaneously injected immunomodulatory drug glatiramer acetate (Copaxone, Glatopa, and generics) about a risk of anaphylaxis. Glatiramer...
- Comparison Chart: Interleukin (IL) Receptor Antagonists for Atopic Dermatitis (online only) View the Comparison Chart: Interleukin (IL) Receptor Antagonists for Atopic Dermatitis
- Cosibelimab (Unloxcyt) for Cutaneous Squamous Cell Carcinoma (online only) Cosibelimab (Unloxcyt – Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, has been approved by the FDA for treatment of locally advanced or metastatic cutaneous...
- Ensartinib (Ensacove) for Non-Small Cell Lung Cancer (online only) The FDA has approved ensartinib (Ensacove – Xcovery), an oral kinase inhibitor, for treatment of anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung...
- Remestemcel-L (Ryoncil) for Graft-Versus-Host Disease (online only) Remestemcel-L (Ryoncil – Mesoblast), an allogeneic bone marrow-derived mesenchymal stromal cell therapy, has been approved by the FDA for treatment of steroid-refractory acute graft-versus-host...
February 3, 2025 (Issue 1721)
- Drugs for Irritable Bowel Syndrome Irritable bowel syndrome (IBS) is a common disorder characterized by recurrent abdominal pain and altered bowel habits, often accompanied by bloating. IBS is classified by its predominant bowel...
- Comparison Chart: Safety of Drugs for IBS in Pregnancy and Lactation (online only) View the Comparison Chart: Safety of Drugs for IBS in Pregnancy and Lactation
- Figure 1: Treatments for Irritable Bowel Syndrome (IBS) in Adults (online only) View Figure: Treatments for Irritable Bowel Syndrome (IBS) in Adults
- Comparison Chart: Some Drugs for Abdominal Pain in Irritable Bowel Syndrome (IBS) (online only) View the Comparison Chart: Some Drugs for Abdominal Pain in Irritable Bowel Syndrome (IBS)
- Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Constipation (IBS-C) (online only) View the Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Constipation (IBS-C)
- Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Diarrhea (IBS-D) (online only) View the Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Diarrhea (IBS-D)
January 20, 2025 (Issue 1720)
- Valeda Light Delivery System for Age-Related Macular Degeneration The FDA has authorized use of the Valeda Light Delivery System (LumiThera), a multiwavelength photobiomodulation (PBM) device, to improve visual acuity in patients with dry age-related macular degeneration...
- Emrosi — Low-Dose, Biphasic Oral Minocycline for Rosacea Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea...
- Dupilumab (Dupixent) for COPD The FDA has approved the subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of adults with inadequately...
- Seladelpar (Livdelzi) for Primary Biliary Cholangitis Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid...
- Zenocutuzumab (Bizengri) for NSCLC and Pancreatic Adenocarcinoma Zenocutuzumab (Bizengri – Merus), a bispecific HER2- and HER3-directed antibody, has received accelerated approval from the FDA for treatment of advanced, unresectable or metastatic non-small cell lung...
- Zanidatamab (Ziihera) for Biliary Tract Cancer (online only) Zanidatamab-hrii (Ziihera – Jazz), a bispecific HER2-directed antibody, has received accelerated approval from the FDA for treatment of unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer...
January 6, 2025 (Issue 1719)
- Drugs for Age-Related Macular Degeneration Age-related macular degeneration (AMD) has two major forms: dry or non-neovascular (~90% of patients) and wet or neovascular (~10% of patients).
- Qlosi — Pilocarpine 0.4% Ophthalmic Solution for Presbyopia The FDA has approved pilocarpine 0.4% preservativefree ophthalmic solution (Qlosi – Orasis) for treatment of presbyopia in adults. Pilocarpine 1.25% ophthalmic solution (Vuity) was approved in 2021 for the...
- Vyalev — Foscarbidopa/Foslevodopa Subcutaneous Infusion for Parkinson's Disease Vyalev (Abbvie), a solution for continuous subcutaneous infusion containing the prodrugs foscarbidopa and foslevodopa, has been approved by the FDA for treatment of motor fluctuations in adults...
- Revumenib (Revuforj) for Acute Leukemia (online only) Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A...