ARS Pharmaceuticals, Inc. got an ahead-of-schedule US Food and Drug Administration approval for its inhaled formulation of epinephrine for severe allergy attacks on 9 August and is now preparing to launch what one of its executives called “clearly a multibillion market opportunity” during a 12 August call with investors. Called neffy, the product is the first needle-free therapy for type 1 allergic reactions and will compete directly with EpiPen and other injectable epinephrine products, including a generic product from Teva Pharmaceutical Industries Ltd.
Key Takeaways
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Following a complete response letter last September, ARS obtained FDA approval of neffy, the first needle-free epinephrine therapy for severe allergy attacks.
The US approval follows an FDA complete response letter last September that changed what had been a post-marketing requirement for...
