ARS Pharmaceuticals issued CRL by FDA for neffy NDA, plans to appeal

ARS Pharmaceuticals announced that the FDA issued a Complete Response Letter, or CRL, regarding its New Drug Application, or NDA, for neffy in the treatment of Allergic Reactions, including anaphylaxis for adults and children of 30 kg. ARS Pharma plans to submit a Formal Dispute Resolution Request, or FDRR, to appeal the issuance of this CRL. In the letter, the FDA requested completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval. This request comes after the recommendation of the FDA Advisory Committee, or PADAC, in May to approve neffy without the need for additional studies to demonstrate its efficacy or safety. Further, FDA and ARS Pharma previously aligned in August on final physician’s labeling and a post-marketing requirement to conduct this study as informative for labeling. The PADAC meeting was held on May 11 and concluded a favorable benefit-risk profile of neffy, with a 16:6 vote in favor for adults and 17:5 vote in favor for children for the treatment of patients with allergic reactions, including anaphylaxis. In that session, no member of the Committee raised specific concerns about the result of the completed study in people with allergen-induced acute rhinitis with single-dose neffy, which showed enhanced absorption during the time period when a clinical response would be expected. As ARS Pharma previously agreed with FDA to conduct a repeat-dose study under allergen-induced allergic rhinitis conditions as a post-marketing commitment, ARS Pharma anticipates a resubmission to the FDA in the first half of 2024, positioning ARS Pharma for an anticipated FDA action date in the second half of 2024. ARS Pharma expects to have anticipated cash, cash equivalents and short-term investments on hand of approximately $195M at the time of the anticipated launch of neffy, if approved in the second half of 2024.The CRL requested additional information on nitrosamine impurities to be tested for based on new draft guidance issued after the neffy NDA submission. ARS Pharma does not believe the additional testing would be a rate-limiting step for its resubmission to the FDA. A marketing authorization application for neffy is also under review by the European Medicines Agency with a Committee for Medicinal Products for Human Use opinion expected by year end 2023. Submissions to other regulatory authorities in additional countries are planned for 2024.