FDA News Month in Review: February 2025

Credit: HCPLive

Welcome back to our recap of this month's news and updates from the US Food and Drug Administration (FDA)!

In our February 2025 recap, we spotlight 8 FDA decisions, including 7 approvals or clearances and 1 Refusal to File letter. Be sure to subscribe for a recap of the therapies, companies, and individuals moving the needle in healthcare during the past month, delivered on the first Saturday of each new month!

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

FDA News Month in Review: February 2025

FDA Approves Susvimo for Diabetic Macular Edema

On February 04, 2025, Genentech announced FDA approval for Susvimo (ranibizumab injection) for diabetic macular edema. Based on clinical trial data showing sustained vision improvements with twice-yearly dosing, Susvimo offers a less frequent treatment option for patients managing this chronic eye condition.

FDA Approves Emblaveo Combination Antibiotic Therapy for Complicated Intra-Abdominal Infections

On February 07, 2025, Pfizer announced FDA approval for Emblaveo (aztreonam-avibactam) for the treatment of complicated intra-abdominal and urinary tract infections. Based on clinical trial data demonstrating efficacy against multidrug-resistant gram-negative bacteria, Emblaveo offers a new option for patients with limited treatment alternatives.

FDA Expands Dosing Label for Avacincaptad Pegol for Geographic Atrophy

On February 13, 2025, Astellas Pharma announced the FDA's approval of an expanded label for avacincaptad pegol intravitreal solution (IZERVAY) for the treatment of geographic atrophy (GA), extending its approved dosing beyond 12 months. Based on 2-year data from the Phase 3 GATHER2 trial, the treatment showed a continued reduction in GA lesion growth, with benefits observed as early as 6 months and improving over time. This approval provides greater flexibility for long-term disease management in patients with GA, a chronic and progressive condition leading to vision loss.

FDA Approval Announced for 2 New Injectable Hyaluronic Acid, Dermal Filler Gels

On February 13, 2025, Evolus, Inc. announced that the FDA approved two injectable hyaluronic acid gels, Evolysse Form and Evolysse Smooth, marking the company's first expansion into the hyaluronic acid dermal filler market. Based on a pivotal study, both products demonstrated safety, efficacy, and versatility, outperforming Restylane-L in treatment of nasolabial folds, with significant improvements noted at various time points. These products are expected to be available in the second quarter of 2025, offering a new option for achieving natural-looking, long-lasting aesthetic results.

FDA Approves Merilog, Biosimilar Product of Insulin Aspart (Novolog) for Diabetes

On February 14, 2025, the FDA approved insulin-aspart-szjj (Merilog) as a biosimilar to insulin aspart (Novolog) for the treatment of glycemic control in adults and pediatric patients with diabetes mellitus. Based on its approval as the first rapid-acting insulin biosimilar, this product offers a more affordable option for managing mealtime blood sugar and improving overall blood sugar control. The approval provides both a 3 mL single-use prefilled pen and a 10 mL multiple-dose vial, increasing access to essential diabetes treatment.

FDA Clears GlutenID Test for Easier Celiac Screening

On February 17, 2025, the FDA cleared Targeted Genomics’ Direct-to-Consumer GlutenID test to identify genetic health risk for celiac disease. Based on next-generation sequencing of at-home collected saliva samples, the test assesses key genetic markers and reports risk levels or indicates a low chance of developing celiac disease. This approval provides a simplified way for individuals to understand their inherited risk, though it encourages consultation with a healthcare provider before making dietary changes.

FDA Rejects Pitolisant NDA for Idiopathic Hypersomnia

On February 19, 2025, Harmony Biosciences announced that the FDA issued a Refusal to File (RTF) letter for its sNDA for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH). Based on the FDA's feedback, the company will proceed with a planned Phase 3 registrational trial in Q4 2025 to further demonstrate pitolisant's benefit in IH, despite the earlier study's failure to meet its primary endpoint. Harmony remains committed to advancing pitolisant-based treatments, with plans to develop a higher-dose formulation, Pitolisant HD.

FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment

On February 24, 2025, Indivior announced that the FDA approved the prior supplement submission for buprenorphine extended-release injection (SUBLOCADE) to treat opioid use disorder (OUD). This update expands the subcutaneous injection site options to include the thigh, buttock, and upper arm for both induction and maintenance, in addition to the abdomen. The approval also reduces the induction time, allowing for a single dose of transmucosal buprenorphine with a 1-hour observation period. Data from clinical trials demonstrate SUBLOCADE’s efficacy in increasing opioid abstinence and its safety profile, including common injection site reactions and mild adverse events.

Related Content: New Buprenorphine Label Allows Physician-Informed Treatment of Opioid Use Disorder, with Bobby Mukkamala, MD