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ARS Gets Early FDA Approval For Needle-Free Epinephrine

ARS Will Take On Injectable Epinephrine Products With FDA-Approved Neffy

 
• By Joseph Haas

ARS will compete directly with EpiPen and other injectable products with inhaled neffy as the first needle-free epinephrine therapy for severe allergy attacks. EU approval is thought imminent.

Allergies
• Source: Shutterstock

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

  • Following a complete response letter last September, ARS obtained FDA approval of neffy, the first needle-free epinephrine therapy for severe allergy attacks.

  • The company told an investor call its sees significant early adoption opportunity among patients prescribed but not using or refilling EpiPen and similar injectable products

The US approval follows an FDA complete response letter last September that changed what had been a post-marketing requirement for a repeat-dosing study of the nasal spray to a pre-approval requirement

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