FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for neffy® for the Treatment of Allergic Reactions (Type I), Including Anaphylaxis
New Drug and Marketing Authorization Applications for neffy Under Review with FDA and EMA, Respectively; FDA PDUFA Target Action Date Anticipated mid-2023
$264.5 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three Years, Including the Planned Commercialization of neffy in the United States
SAN DIEGO, May 15, 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 highlighted recent progress and reported first quarter 2023 financial results.
“For the millions of people living with Type I allergic reactions including anaphylaxis, we believe that neffy (nasal epinephrine spray), a small, needle-free and easy-to-use nasal spray, could provide a much-needed alternative to the currently approved epinephrine injection devices. Despite their effectiveness, these devices are limited in usage because many patients and caregivers do not carry, avoid using or hesitate to use them,” said Richard Lowenthal, president and chief executive officer of ARS Pharmaceuticals. “Throughout the first quarter, we’ve made important strides toward bringing neffy to patients. We are glad to have had the opportunity to discuss neffy with the FDA’s Advisory Committee during our recent meeting and are incredibly pleased with the outcome and the committee’s support of neffy for adults and children.”
Eric Karas, chief commercial officer added, “As we look ahead, with both our NDA and MAA for neffy currently under review by the regulators in the U.S. and EU, we are laser focused on our commercial preparedness activities. Over the last several months, we’ve made significant progress in our Commercial Launch Readiness. We are preparing to launch a 125-person salesforce focusing on specialists and healthcare providers who prescribe epinephrine and will have an array of patient and provider services established to ensure affordability. Access to neffy is a key focus and priority for us, and we have started to work with drug benefit plans to educate and raise awareness about new routes of administration that will help ensure the prompt use of epinephrine for severe allergic reactions, including anaphylaxis.”
neffy® Progress
- FDA Advisory Committee Supports neffy Potential for the Treatment of Allergic Reactions (Type I), Including Anaphylaxis, Under Review with FDA and EMA: The U.S. Food and Drug Administration’s (FDA) held a Division of Pulmonary-Allergy Drug Advisory Committee (PADAC) meeting on May 11, 2023, to review the New Drug Application (NDA) for neffy. The committee voted 16:6 in favor for adults, and 17:5 in favor for children (