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EURneffy (adrenaline nasal spray) Approved in the EU as the First and Only Needle-Free Emergency Treatment of Allergic Reactions (anaphylaxis)
EURneffy offers adults and children (≥30 kg) in Europe living with severe allergic reactions the first new delivery method for adrenaline in more than 30
About this update from Ars Pharmaceuticals, Inc.
[{"type":"text","content":"EURneffy offers adults and children (≥30 kg) in Europe living with severe allergic reactions the first new delivery method for adrenaline in more than 30 years in the EU European Commission decision follows FDA approval in the United States on August 9, 2024 SAN DIEGO, Aug. 26, 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 European Commission has approved EURneffy® (adrenaline nasal spray) for the emergency treatment of allergic reactions (anaphylaxis) on August 22, 2024. “Adrenaline is the only first-line treatment for allergic reactions including anaphylaxis, yet there is significant underutilization of adrenaline due to the limitations of current available therapy,” said Antonella Muraro, MD PhD, Professor of Food Allergy at the University of Padua, and lead author of the European Academy of Allergology and Clinical Immunology (EAACI) treatment guidelines for anaphylaxis, “The approval of EURneffy provides the first needle-free treatment option available in the EU for adults and children (≥30 kg) with severe allergies, many of whom may not carry, or delay use of an injectable adrenaline product.” “Today’s approval marks an important moment for the severe allergy community in the EU, and the first novel adrenaline delivery method in more than three decades,” 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 the outcome of allergic reactions.” 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-a...