May 11, 2023
FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis
ARS Pharmaceuticals, Inc., 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’s (FDA) Pulmonary-Allergy Drug Advisory Committee (PADAC) voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30 kg), 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. If approved, it could be available in the second half of 2023.
Visit ARS-Pharma to learn more.