FDA extends target action date for epinephrine nasal spray to September
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The FDA has extended the prescription drug user fee act target action date for the new drug application for neffy intranasal epinephrine spray from ARS Pharmaceuticals to Sept. 19, according to a company press release.
The spray is designed to treat type 1 allergic reactions including anaphylaxis in adults and children who weigh 30 kg or more. Unlike epinephrine autoinjectors, neffy does not use a needle or require an injection.
After the FDA Pulmonary-Allergy Drug Advisory Committee (PADAC) conducted a favorable benefit-risk assessment on May 11, ARS Pharmaceuticals said, the FDA told the company that it needed additional time to complete its review.
The FDA did not request any additional premarketing studies, ARS Pharmaceuticals said, adding that it has addressed all the FDA’s other requests for information. The company also said that the additional time is needed for labeling and post-marketing commitment discussions about the medication.
Further, ARS Pharmaceuticals said, it has submitted proposals for post-marketing commitments based on input from the May PADAC meeting.
“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,” Richard Lowenthal, MS, MSEL (MBA), cofounder, president and CEO of ARS Pharmaceuticals, said in the release.
“While the agency extended the [prescription drug user fee act] 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,” Lowenthal said.
Food Allergy Research and Education (FARE) released a statement from Sung Poblete, RN, PhD, in which the FARE CEO acknowledged the importance of patient access to safe and effective options for allergic reactions including anaphylaxis, which can be life-threatening.
A needle-free option can have a positive impact on individuals with food allergies, including those individuals who have a fear of using needles, according to Poblete.
“We remain optimistic that the extended review period for neffy will lead to approval of a needle-free option to treat anaphylaxis with reduced anxiety and less hesitation,” Poblete said in the statement.
The European Medicines Agency is reviewing a marketing authorization application for neffy as well, with ARS Pharmaceuticals expecting a decision there in early 2024.
Reference:
- Statement by Sung Poblete, RN, PhD, CEO of FARE, regarding FDA’s extended PDUFA target action date for neffy (intranasal (IN) epinephrine) for allergic reactions. https://www.foodallergy.org/media-room/statement-sung-poblete-rn-phd-ceo-fare-regarding-fdas-extended-pdufa-target-action-date. Published June 20, 2023. Accessed June 21, 2023.