ARS Pharmaceuticals announces EC approval for EURneffy

ARS Pharmaceuticals announced that the European Commission has approved EURneffy for the emergency treatment of allergic reactions on August 22, 2024. The approval of the mixed application for marketing authorization grounded on Article 8(3) of Directive 2001/83/EC by the European Commission was granted following the review of 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 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. EURneffy benefits from an eight-year period of data protection whereby another applicant cannot rely the data submitted as part of the EURneffy marketing authorization application, and a ten-year period of marketing protection during which a generic, hybrid or biosimilar cannot be placed on the market in the EU. The issued composition of matter and method of treatment patents covering EURneffy in Europe expire in 2039. ARS Pharma anticipates that EURneffy will be made available to patients in certain European Union Member States in Q4 2024 by a pharmaceutical company with an already established commercial footprint in Europe.