11 May 2023 – PLC commends ARS Pharmaceuticals for their recent favorable FDA Advisory Committee vote on the benefit-risk profile for neffy®. The Advisory Committee voted that neffy data supports a favorable benefit-risk assessment in adults and in children <18 years of age. PLC has supported ARS with Regulatory filings and clinical trial oversight since the early development phases of their epinephrine nasal spray for the treatment of severe allergic reactions including anaphylaxis.
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
- FDA Advisory Committee Votes: neffy Data Support a Favorable Benefit-Risk Assessment in Adults (16:6 in Favor) and in Children <18 years of age and ≥30 kg (17:5 in Favor)
- If Approved, neffy Will Become the First Needle-Free Epinephrine Product for the Treatment of Severe Allergic Reactions
- FDA Approval Decision Anticipated Mid-2023