The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has scheduled a meeting on May 11, 2023 to review the ARS Pharmaceuticals’ NDA for Neffy intranasal epinephrine for the treatment of anaphylaxis and other Type 1 allergic reactions. The FDA accepted the NDA for review in October 2022.
Public comments may be submitted up to April 27 for delivery to the committee prior to the meeting. Additional comments will be accepted through May 10, 2023. The docket number is FDA-2023-N-0984.
ARS President and CEO Richard Lowenthal commented, “The majority of patients with Type 1 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. 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.”
Read PADAC meeting information.
Read the ARS Pharmaceuticals press release.
