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ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)
EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in Europe Positive CHMP opinion and recommendation for approval of a mixed application for marketing authorization based on comprehensive data package comparing EURneffy to approved injectable products across a range of dosing scenarios as well as supportive historical data from injectable products Same data package under review by FDA with a PDUFA date of October 2, 2024 SAN DIEGO, June 28, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to the development of products to better protect patients from severe allergic reactions that could lead to anaphylaxis, announced today 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 Q3 2024. “Today’s announcement marks a major milestone in the treatment of severe allergies and moves us one step closer to bringing EURneffy to patients in the EU as the first and only needle-free adrenaline option for the emergency treatment of allergic reactions, up to anaphylaxis,” said Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma. “EURneffy’s needle-free, smaller form and longer and less temperature-sensitive shelf-life may increase the likelihood that patients will both carry and administer adrenaline, which improves outcome of allergic reactions.” 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 sup...