ARS Pharmaceuticals Announces PDUFA Date Extension for neffy (Intranasal (IN) Epinephrine) for the Treatment of Allergic Reactions (Type 1), Including Anaphylaxis

Additional Time Needed for Labeling and Post-Marketing Requirements Discussions; PDUFA Date Set for September 19, 2023

SAN DIEGO, June 20, 2023 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), 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 (FDA) extended the Prescription Drug User Fee Act (PDUFA) target action date by three months for the New Drug Application (NDA) for neffy (Intranasal (IN) Epinephrine) for the treatment of allergic reactions (Type 1), including anaphylaxis, for adults and children ≥30 kg. The updated PDUFA target action date is September 19, 2023.

Following a favorable benefit-risk assessment by the FDA Pulmonary-Allergy Drug Advisory Committee (PADAC) meeting on May 11, 2023, the Agency informed ARS that it requires additional time to complete its review; however, no additional pre-marketing studies have been requested and ARS has addressed all other information requests from the Agency to date. The additional time is needed for labeling and post-marketing commitment discussions regarding neffy, and ARS has submitted proposals for post-marketing commitments based on input from the PADAC meeting in May.

“FDA is working on labeling and post-marketing commitments as the final steps in the review process,” said Richard Lowenthal, Co-Founder, President and Chief Executive Officer, ARS Pharmaceuticals. “Following the strong endorsement of our clinical data for neffy at the May PADAC meeting, there was limited time to address any final questions and complete labeling. While the Agency extended the PDUFA timeline, we are hopeful that labeling discussions will be completed as soon as possible given the significant unmet need in the allergy community for a needle-free option that is easily carried and administered without anxiety or hesitation.”

In addition, a marketing authorization application for neffy is under review by the European Medicines Agency with a decision expected in early 2024.

For more information, visit: https://ars-pharma.com/

About Type I Allergic Reactions, including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 25 to 40 million people in the United States who experience Type I severe allergic reactions. Of those, only 3.3 million currently have an active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector. Even if patients or caregivers carry an autoinjector, more than half either delay or do not administer the device when needed in an emergency.