ARS Pharmaceuticals Announces FDA Advisory Committee for neffy® for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis

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[{"type":"text","content":"SAN DIEGO, March 28, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Division of Pulmonology, Allergy and Critical Care Advisory Committee meeting on May 11, 2023 to review the new drug application (NDA) for neffy®. neffy has the potential to be the first, non-injectable epinephrine nasal spray medicine for the treatment of patients with allergic reactions (type 1), including anaphylaxis. The FDA stated the following regarding an Advisory Committee in its official pre-NDA meeting minutes received by ARS: An Advisory Committee is an important aspect of the review given the new route of administration for an emergency use product that has clinical efficacy trial feasibility issues.Additional experts with knowledge in systemic allergic reactions and anaphylaxis will be invited to participate in the Advisory Committee.The FDA would not be planning to bring ARS’s application to an Advisory Committee if they did not feel the PK/PD provided by ARS had the potential for approval. “The majority of patients with type I allergic reactions including anaphylaxis have limited or unsatisfactory treatment options in real-world community settings because of reluctance to administer or carry their injectable epinephrine devices,” said Richard Lowenthal, president and chief executive officer of ARS Pharmaceuticals. “The announcement to hold an Advisory Committee is in-line with our historical interactions with the FDA over the years, and we believe a positive step towards the potential approval of neffy. We are excited to have the opportunity to discuss neffy with the FDA and the Advisory Committee.” The Company’s NDA submission for neffy was accepted for review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date anticipated in mid-2023. About Type I Allergic Reactions including Anaphylaxis Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine aut...

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