ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company’s MAA for Neffy epinephrine nasal spray to the EMA’s Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the MAA by mid-2024. The company said that it received Day 180 comments in late 2023 requesting results from a repeat dose study of Neffy under nasal allergen challenge conditions and additional nitrosamine testing.
ARS Pharma announced in February 2024 that it had completed the repeat dose nasal allergen challenge study, which had also been requested by the FDA when the US agency issued a complete response letter to the company’s NDA for Neffy. ARS recently submitted its response to the CRL.
In addition to the Day 180 response, the company announced that CSL Seqirus has acquired development and distribution rights to Neffy for Australia and New Zealand. CSL Seqirus Executive Director of Commercial Operations Asia-Pacific Danielle Dowell commented, “We’re thrilled to be partnering with an innovative company in ARS Pharma to work towards making this innovative needle free adrenaline device for anaphylaxis treatment available for people in Australia and New Zealand who live with severe allergies.”
ARS Pharma President and CEO Richard Lowenthal said, “We are encouraged that CSL Seqirus recognizes the importance of making a needle-free epinephrine treatment available to severe allergy patients in Australia and New Zealand, as well as by the robust and compelling Neffy product profile and registrational data as we pursue final approval globally. CSL Seqirus is not only one of the leading fully integrated commercialization partners for vaccines and pharmaceuticals in Australia and New Zealand, but it has a proven track record of successfully commercializing multiple innovative medicines that it has in-licensed for its allergy portfolio over the years.”
Read the ARS Pharmaceuticals press release.
