The Medical Letter - 2025
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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...