ARS Pharmaceuticals: EURneffy recommended for approval by CHMP

ARS Pharmaceuticals announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion on the application for marketing authorization for EURneffy and recommended related market authorization in the European Union for the emergency treatment of allergic reactions. The CHMP positive opinion will now be submitted to the European Commission for the formal marketing authorization process, which is expected to occur in Q3 2024. Following grant of marketing authorization by the EC expected in Q3 2024, ARS Pharma anticipates that EURneffy will be made available to patients in Europe in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe. The same data package reviewed by CHMP that resulted in its positive opinion and approval recommendation was submitted to the U.S. FDA on April 2, 2024. FDA acknowledged receipt of the submission and considered it a complete response to the September 19, 2023 action letter with no comments. The company’s New Drug Application is under review by FDA, with a neffy PDUFA action date assigned by the FDA of October 2, 2024.