FDA Approves ARS Pharma's Neffy Spray for Pediatric Anaphylaxis

The FDA has approved ARS Pharmaceuticals' neffy 1 mg nasal spray for treating type I allergic reactions, including anaphylaxis, in pediatric patients aged 4 and older weighing between 15 and 30 kg. This needle-free epinephrine option is seen as a significant advancement in allergy treatment, providing a simpler and less intimidating alternative to traditional auto-injectors like EpiPen. ARS Pharma anticipates that neffy will be available in U.S. pharmacies by the end of May 2025, with an expected cost of $199 for two doses, although a co-pay savings program will cap costs at $25 for many insured patients. The approval follows the earlier authorization of a 2 mg version for patients weighing over 30 kg and aims to improve access for younger children, potentially transforming emergency allergy treatments. Company CEO Richard Lowenthal emphasized the importance of this development in making severe allergy management more accessible and effective for families. Analysts predict that this approval will lead to increased prescriptions, especially as the back-to-school season approaches.