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Agency cites a need for more research to be completed.
ARS Pharmaceuticals revealed in a company press release that the FDA issued a complete response letter (CRL) regarding its new drug application (NDA) for neffy, a potential nasal spray alternative to the EpiPen. According to the response, the agency stated that it needed more research before agreeing to approval. The denial comes amid an initial advisory committee vote to approve the treatment back in May.
“We are very surprised by this action and the late requirement at this time to change the repeat-dose study from a post-marketing requirement, which we had previously aligned on with FDA, to a pre-approval requirement, particularly given the positive Advisory Committee vote. In fact, multiple Committee members highlighted the favorable profile of neffy in our completed single-dose nasal allergy challenge study and that any decline in exposure 20 minutes after dosing, after the expected response period, is of no concern,” said Richard Lowenthal, co-founder, president, CEO, ARS Pharma, in a company press release. “We stand by the totality of the neffy data package generated in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value neffy can provide for patients, families and caregivers living daily with severe allergic reactions.”
Reference: FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study. Globe Newswire. September 19, 2023. Accessed September 20, 2023. https://www.globenewswire.com/news-release/2023/09/20/2746095/0/en/FDA-Issues-Complete-Response-Letter-for-neffy-epinephrine-nasal-spray-New-Drug-Application-with-Request-for-Additional-Study.html