Drugs.com - Monthly Update March 2026
Welcome to the March 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.
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This month, we delve into some FDA approvals that could significantly impact patient care. Today, we're touching on Wegovy's new high-dose approval for chronic weight management in obesity, Icotyde as a first oral IL-23 blocker for plaque psoriasis, Sotyktu's approval for active psoriatic arthritis, and Awiqli as a once-weekly basal insulin injection for type 2 diabetes. These developments highlight exciting advancements in therapeutic areas ranging from autoimmune disorders to weight management, offering new options for healthcare providers and patients alike.
Let's start with Wegovy HD, spelled W-E-G-O-V-Y H-D. This higher dose of semaglutide was recently approved by the FDA for chronic weight management in adults with obesity. The new Wegovy HD formulation offers a dose of 7.2 mg administered under the skin via an injectable pen. This is a notable increase from the previously approved 2.4 mg dose. In the 72-week STEP UP study, adults tolerated this higher dose and achieved a 21% average body weight reduction. This was compared to an 18% reduction at the 2.4 mg dose and much less on placebo. With about 31% of participants achieving 25% or greater weight loss, this could be a new option for those struggling to manage their weight effectively. Side effects of the higher dose include nausea, vomiting, constipation, abdominal pain, and unpleasant skin sensations, among others.
Moving on to dermatology, the FDA has also cleared Icotyde, spelled I-C-O-T-Y-D-E, as the first oral IL-23 blocker for moderate-to-severe plaque psoriasis. This skin condition causes uncomfortable, scaly plaques that can affect patients' lives significantly. Icotyde works by selectively inhibiting the interleukin-23 receptor, a key player in the inflammation process. Results from the Phase 3 ICONIC program indicated that Icotyde produced remarkable improvement with a significant number of patients achieving clear or near-clear skin at 16 weeks. It's administered as a 200 mg oral tablet taken once daily and provides a convenient option for patients, particularly those hesitant about injectable therapies. Side effects to monitor include headache, nausea, and cough as the most reported.
In rheumatology, Sotyktu, spelled S-O-T-Y-K-Y-U, offers a new approach for adults with active psoriatic arthritis. It inhibits the tyrosine kinase 2 enzyme and is taken as a 6 mg oral once-daily dose. This approval rests on its performance in clinical trials showing a 20% or greater improvement in joint and symptom measures in around 54% of participants at week 16 versus placebo. Patients and clinicians should be aware of potential serious side effects like infections and elevated liver enzymes.
Lastly, for type 2 diabetes, the FDA approved Novo Nordisk’s Awiqli, spelled A-W-I-Q-L-I. This once-weekly injection contains insulin icodec, a long-acting human insulin analog designed to cover basal insulin requirements. Clinical trials showed that once-weekly Awiqli improved A1c in adults with type 2 diabetes and had a similar safety profile as daily basal insulin. Common side effects include low blood sugar and injection-site reactions.
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.
