FDA Panel Votes In Favor Of ARS Pharma's Neffy For Allergic Reactions Treatment

(RTTNews) - ARS Pharmaceuticals Inc. (SPRY) said that the U.S. Food and Drug Administration's Pulmonary-Allergy Drug Advisory Committee (PADAC) voted 16:6 in favor for adults, and 17:5 in favor for children, that available data support a favorable benefit-risk assessment for neffy in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg.

While PADAC recommendations are non-binding, the FDA will consider this outcome in its review of the pending New Drug Application (NDA) for neffy.

The company noted that the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date anticipated mid-2023. If approved, neffy would be the first non-injectable treatment available to patients with allergic reactions (Type 1) including anaphylaxis.

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