FDA Advisory Committee votes in support of favorable bnefit-risk profile for neffy (intranasal for the treatment of allergic reactions (type 1), including anaphylaxis.- ARS Pharmaceuticals, Inc
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, announced that the 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.
The PADAC decision was based on a review of comprehensive data from clinical studies developed in agreement with the FDA, which support a positive risk-benefit profile for intranasal (IN) epinephrine safety and effectiveness, compared to epinephrine injection.
The studies demonstrated and the Committee’s discussion supported that neffy shows: i. Comparable pharmacokinetic (PK) data (epinephrine levels in the blood) vs. intramuscular injection including the first 10 to 20 minutes when clinical response is observed. ii. Comparable or greater pharmacodynamic (PD)response (systolic blood pressure and heart rate) vs. intramuscular injection that is observed even at 1 minute after dosing of neffy. iii. Effective IN delivery of systemic epinephrine and PD response even with nasal congestion or runny nose (e.g., during allergic rhinitis or upper respiratory tract infection). iv. Comparable safety to injection that is generally mild in nature without any meaningful nasal irritation or pain, without needle-related risks.
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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