ARS Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion on the application for marketing authorization for EURneffy (adrenaline nasal spray) and recommended related market authorization in the European Union (EU) for the emergency treatment of allergic reactions (anaphylaxis). The CHMP positive opinion will now be submitted to the European Commission (EC) for the formal marketing authorization process, which is expected to occur in third quarter 2024. The positive opinion and recommendation for approval of a mixed application for marketing authorization grounded on Article 8(3) of Directive 2001/83./EC from the CHMP is based on data from one of the most extensive nasal spray development programs in history involving more than 700 study participants and over 1,200 administrations, as well as studies and peer-reviewed literature substituting or supporting certain tests and studies.

The basis of approval for EURneffy in Europe was efficacy supported by surrogate pharmacodynamic endpoints. The pharmacodynamics and pharmacokinetics of 2 mg EURneffy were evaluated across a range of dosing conditions, including single and repeat dosing, self-administration by patients, dosing in pediatrics, and during multiple nasal conditions that can cause congestion and rhinorrhea such as nasal allergen challenge or infectious rhinitis caused by a cold/flu. The EURneffy mixed application under Article 8(3) of Directive 2001/83./EC will benefit from an eight-year period of data protection whereby another applicant cannot rely on support from the EURneffy application, and a ten-year period of marketing protection during which a generic, hybrid or biosimilar cannot be placed on the market.

The issued composition of matter and method of treatment patents covering EURneffy in Europe have an expiration date in 2039. Following grant of marketing authorization by the EC expected in third quarter 2024, ARS Pharma anticipates that EURneffy will be made available to patients in Europe in fourth quarter 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. Food and Drug Administration (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. EURneffy is the trade name for neffy (epinephrine nasal spray) in the European Union.