The Medical Letter - 2024
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April 29, 2024 (Issue 1701)
- Resmetirom (Rezdiffra) for Metabolic Dysfunction-Associated Steatohepatitis Resmetirom (Rezdiffra – Madrigal), a thyroid hormone receptor-beta agonist, has received accelerated approval from the FDA for treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with...
- A New Indication for Semaglutide (Wegovy) The injectable glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide (Wegovy) has been approved by the FDA to reduce the risk of major adverse cardiovascular events (MACE) in adults with established...
- Intravenous Acetaminophen/Ibuprofen (Combogesic IV) The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in...
- iDose TR — A Travoprost Implant for Glaucoma The FDA has approved iDose TR (Glaukos), an intracameral implant containing the prostaglandin analog (PGA) travoprost, for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or...
- Antibiotic Prophylaxis for Dental Procedures Since 2007, antimicrobial prophylaxis for dental procedures has been recommended to prevent viridans group streptococcal infective endocarditis only for patients at highest risk of an adverse outcome....
- Tepotinib (Tepmetko) for NSCLC (online only) The FDA has granted regular approval to the oral kinase inhibitor tepotinib (Tepmetko – EMD Serono) for treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring...
- Belzutifan (Welireg) for Advanced Renal Cell Carcinoma (online only) Belzutifan (Welireg – Merck), a first-in-class hypoxia-inducible factor inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma (RCC) in adults who received prior treatment...
- Lifileucel (Amtagvi): A Cellular Therapy for Melanoma (online only) Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma...
April 15, 2024 (Issue 1700)
- Roflumilast Foam (Zoryve) for Seborrheic Dermatitis The FDA has approved a 0.3% foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of seborrheic dermatitis in patients ≥9 years old....
- Cabtreo: A Three-Drug Gel for Acne The FDA has approved Cabtreo (Bausch Health), a gel containing the retinoid adapalene, the oxidizing agent benzoyl peroxide, and the antibiotic clindamycin, for treatment of acne vulgaris in patients ≥12...
- Zilucoplan (Zilbrysq) for Myasthenia Gravis The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor...
- Donislecel (Lantidra) for Type 1 Diabetes The FDA has approved donislecel-jujn (Lantidra – CellTrans), an allogeneic pancreatic islet cellular therapy, for use in conjunction with immunosuppression for treatment of adults with type 1 diabetes who...
April 1, 2024 (Issue 1699)
- Drugs for Bipolar Disorder Bipolar disorder is characterized by episodes of mania, hypomania, and depression. Recurrences of manic or (more frequently) depressive symptoms are common. About 15-20% of patients with bipolar disorder...
- Omalizumab (Xolair) for Food Allergy Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also...
- Addendum: Bupropion Safety in Pregnancy Our December 11, 2023 article on Drugs for Depression included a single sentence on the safety of bupropion use during pregnancy: "The safety of bupropion during pregnancy has not been established; data from...
March 18, 2024 (Issue 1698)
- Airsupra: An Inhaled Albuterol/Budesonide Combination for Asthma The FDA has approved Airsupra (AstraZeneca), a metered-dose inhaler containing the short-acting beta2-agonist (SABA) albuterol and the inhaled corticosteroid (ICS) budesonide, for use as needed...
- Penbraya: A Pentavalent Meningococcal Vaccine The FDA has licensed Penbraya (Pfizer), a pentavalent polysaccharide conjugate meningococcal vaccine, for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, B, C, W,...
- Mirikizumab (Omvoh) for Ulcerative Colitis The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first...
- In Brief: A New OTC Naloxone Nasal Spray (RiVive) The FDA has approved RiVive (Harm Reduction Therapeutics), a 3-mg naloxone nasal spray, as an over-the-counter (OTC) product for emergency treatment of opioid overdose. Two 4-mg naloxone nasal spray...
March 4, 2024 (Issue 1697)
- Drugs for Menopausal Symptoms The primary symptoms of menopause are genitourinary and vasomotor. The genitourinary syndrome of menopause (GSM) includes symptoms such as burning, irritation, dryness, dyspareunia, dysuria, and recurrent...
- Tenapanor (Xphozah) for Hyperphosphatemia in Chronic Kidney Disease The FDA has approved the sodium/hydrogen exchanger 3 (NHE3) inhibitor tenapanor (Xphozah – Ardelyx) to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy...
- In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease The FDA is requiring a boxed warning in the label of denosumab (Prolia – Amgen), a monoclonal antibody that inhibits osteoclasts, about an increased risk of severe hypocalcemia in patients with advanced...
February 19, 2024 (Issue 1696)
- Daprodustat (Jesduvroq) for Anemia of Chronic Kidney Disease The FDA has approved daprodustat (Jesduvroq – GSK), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for oral treatment of anemia due to chronic kidney disease (CKD) in adults who...
- Cantharidin Topical Solution (Ycanth) for Molluscum Contagiosum The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for...
- Rozanolixizumab (Rystiggo) for Myasthenia Gravis Rozanolixizumab-noli (Rystiggo – UCB), a neonatal Fc receptor (FcRn) blocker, has been approved by the FDA for treatment of generalized myasthenia gravis in adults with anti-acetylcholine receptor (AChR)...
- Balfaxar: Another Four-Factor PCC for Warfarin Reversal Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent...
- Capivasertib (Truqap) for Breast Cancer (online only) The oral kinase inhibitor capivasertib (Truqap – AstraZeneca), a first-in-class AKT inhibitor, has been approved by the FDA for use in combination with the selective estrogen receptor degrader...
- Fruquintinib (Fruzaqla) for Metastatic Colorectal Cancer (online only) Fruquintinib (Fruzaqla – Takeda), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with metastatic colorectal cancer (mCRC) who received prior fluoropyrimidine-, oxaliplatin-,...
- Repotrectinib (Augtyro) for Non-Small Cell Lung Cancer (online only) The FDA has approved the oral tyrosine kinase inhibitor repotrectinib (Augtyro – BMS) for treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in...
February 5, 2024 (Issue 1695)
- Drugs for Acne Acne is common among adolescents and adults. Guidelines for treatment of acne were last published by the American Academy of Dermatology in 2016.
- Drugs for Rosacea Rosacea is a common, chronic inflammatory facial eruption of unknown cause. It is more prevalent in women than in men, and disease onset typically occurs after age 30. Rosacea is characterized by erythema,...
- Comparison Table: Some Topical Drugs for Rosacea (online only) View the Comparison Table: Some Topical Drugs for Rosacea
- IV Ferric Carboxymaltose (Injectafer) for Iron Deficiency in Heart Failure Ferric carboxymaltose (Injectafer – American Regent) is now FDA-approved for IV treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure to improve...
- Addendum: Drugs for Depression In our article on Drugs for Depression, we should have included tardive dyskinesia (TD) in our list of adverse effects of second-generation antipsychotic (SGA) drugs. TD, which is more commonly associated...
- Addendum: Treatment of Atrial Fibrillation The Interruption of Anticoagulation section of our article on Treatment of Atrial Fibrillation cited the recommendations of the American College of Chest Physicians on perioperative management of antithrombotic...
- In Memoriam Neal H. Steigbigel, M.D. of New York University School of Medicine died on January 13, 2024. His name has been on the masthead of The Medical Letter, fi rst as a member of the Advisory Board and then as a...
January 22, 2024 (Issue 1694)
- Casgevy and Lyfgenia: Two Gene Therapies for Sickle Cell Disease Two cell-based gene therapies – exagamglogene autotemcel (Casgevy – Vertex) and lovotibeglogene autotemcel (Lyfgenia – Bluebird Bio) – have been approved by the FDA for treatment of sickle...
- Bimekizumab (Bimzelx) for Psoriasis The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for...
- Perfluorohexyloctane Ophthalmic Solution (Miebo) for Dry Eye Disease The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in...
- Avacincaptad Pegol (Izervay) for Geographic Atrophy in Age-Related Macular Degeneration The FDA has approved the complement C5 inhibitor avacincaptad pegol (Izervay – Iveric) for intravitreal treatment of geographic atrophy (GA) secondary to age-related macular degeneration...
- Toripalimab (Loqtorzi) for Nasopharyngeal Carcinoma (online only) Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line...
January 8, 2024 (Issue 1693)
- Treatment of Atrial Fibrillation Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of...