The Drugs.com Monthly Update Podcast

Welcome to the May 2026 edition of Drugs.com Monthly Update, where we bring you some of the latest FDA approvals. This episode uses AI tools to help with formatting, organisation, and narration. All content has been reviewed by a senior editorial pharmacist.

This month, we delve into several recent FDA approvals across multiple therapeutic fields. We are reviewing Veppanu for advanced breast cancer, Trimbow for the maintenance treatment of asthma, Xocova for post-exposure prophylaxis of COVID-19, Baxfendy for uncontrolled hypertension, and the prescription-to-OTC switch of Differin Epiduo Acne Gel.

Let's begin with oncology and Veppanu, spelled V-E-P-P-A-N-U. This medication contains vepdegestrant and was approved by the FDA for the treatment of adults with estrogen receptor-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. In the Phase 3 VERITAC-2 clinical trial, vepdegestrant demonstrated a statistically significant improvement in progression-free survival, reducing the risk of disease progression or death by 43% compared to fulvestrant. Veppanu is administered as an oral tablet taken once daily with food. Clinicians should be aware of important warnings regarding QTc interval prolongation and embryo-fetal toxicity, while common adverse events include musculoskeletal pain, fatigue, and nausea.

Next, in respiratory medicine, the FDA approved Trimbow, spelled T-R-I-M-B-O-W. This triple therapy inhaler combines beclomethasone dipropionate, formoterol fumarate and glycopyrrolate - an inhaled corticosteroid, a long-acting beta2-adrenergic agonist, and an anticholinergic agent. It is indicated for the maintenance treatment of asthma in adults. Data from the Phase 3 TRIMARAN and TRIGGER clinical trials in over 2,200 adults showed that Trimbow significantly improved lung function compared to dual therapy. Trimbow is administered by oral inhalation twice daily and carries a limitation of use stating it is not indicated for the relief of acute bronchospasm. Important warnings include the risk of localized Candida albicans infections in the mouth and throat, alongside common side effects like bronchitis, hypertension, and upper respiratory tract infections.

Moving to infectious diseases, the FDA cleared Xocova, spelled X-O-C-O-V-A, as an oral option for the post-exposure prophylaxis of COVID-19. This antiviral medication contains ensitrelvir and is indicated to help prevent infection in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. In the Phase 3 SCORPIO-PEP clinical trial, Xocova met its primary endpoint by demonstrating a 67% reduction in confirmed symptomatic COVID-19 on Day 10 compared to placebo. It is taken orally for 5 days, starting with a 375 mg loading dose on Day 1 followed by 125 mg once daily on Days 2 through 5, and must be initiated within 72 hours of exposure. Key warnings include embryo-fetal toxicity and the potential for significant drug-drug interactions, with common side effects including headache, diarrhea, and cough.

In cardiology, we now look at Baxfendy, spelled B-A-X-F-E-N-D-Y. It contains baxdrostat, a first-in-class, highly selective aldosterone synthase inhibitor. Baxfendy was approved for the treatment of hypertension in combination with other antihypertensive drugs. In the BaxHTN Phase 3 clinical trial, the 2 mg dose of Baxfendy achieved a statistically significant placebo-adjusted reduction in mean seated systolic blood pressure of 9.8 mmHg at week 12. Baxfendy is an oral tablet administered once daily, with or without food. Safety considerations include prominent risks of hyperkalemia and hyponatremia, with elevated potassium levels being the most common adverse reaction reported.

Finally, in dermatology, we have the over-the-counter switch of Differin Epiduo Acne Gel, spelled D-I-F-F-E-R-I-N E-P-I-D-U-O. The FDA approved this topical gel, which combines the retinoid adapalene 0.1% and the antimicrobial benzoyl peroxide 2.5%, for nonprescription, over-the-counter use in individuals aged 12 years and older. This fixed-dose combination targets multiple underlying causes of acne, backed by over 15 years of prescription-strength clinical and real-world evidence demonstrating superior efficacy over individual components. It is applied topically as a thin layer to the affected areas of the face or skin once daily. Users should be cautioned about potential localized skin irritation, dryness, or peeling, and should use appropriate sun protection during use.

Thank you for tuning in to the Drugs.com monthly update podcast, where staying informed means staying ahead in your field. We look forward to bringing you more updates next month. Until next time, know more, be sure.