ARS Pharma’s EURneffy Nasal Spray Recommended for CHMP Approval for Anaphylaxis

SAN DIEGO, June 28, 2024 -- ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company focused on developing treatments for severe allergic reactions, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on the marketing authorization application for EURneffy® (adrenaline nasal spray). The committee has recommended granting market authorization in the European Union (EU) for the emergency treatment of allergic reactions, including anaphylaxis.

The CHMP's positive opinion will be forwarded to the European Commission (EC) for the formal marketing authorization process, which is expected to conclude in the third quarter of 2024. Richard Lowenthal, Co-Founder, President, and CEO of ARS Pharma, described this development as a significant milestone in treating severe allergies, noting that EURneffy will be the first needle-free adrenaline option available in the EU for emergency allergic reactions. He highlighted EURneffy’s advantages, such as its needle-free form, smaller size, and longer shelf-life, which could enhance the likelihood that patients will carry and use the medication, thereby improving outcomes.

The positive opinion is based on data from an extensive nasal spray development program, which included over 700 participants and more than 1,200 administrations. Studies involved different dosing scenarios, including single and repeat dosing, self-administration, pediatric dosing, and various nasal conditions like congestion and rhinorrhea. The pharmacodynamic and pharmacokinetic profiles of 2 mg EURneffy were key factors in the CHMP's decision.

The EURneffy application under Article 8(3) of Directive 2001/83/EC will benefit from an eight-year period of data protection and a ten-year period of market protection, delaying the entry of generic or biosimilar products. The granted patents in Europe for EURneffy cover its composition and method of treatment until 2039.

Once the EC grants marketing authorization, expected in Q3 2024, ARS Pharma plans to make EURneffy available in the European market by the fourth quarter of 2024 through a pharmaceutical partner with an established commercial presence in the region.

The same comprehensive data package reviewed by CHMP was submitted to the U.S. Food and Drug Administration (FDA) in April 2024. The FDA has acknowledged receipt of the submission, considering it a complete response to a prior action letter. The New Drug Application for neffy®, the U.S. trade name for EURneffy, is under FDA review with a PDUFA action date set for October 2, 2024.

Type I severe allergic reactions, including anaphylaxis, are potentially life-threatening and require immediate treatment with epinephrine. While adrenaline auto-injectors are effective, issues such as fear of needles, portability, and complexity often result in delayed or non-administration. EURneffy aims to address these limitations by offering a needle-free solution that could improve patient compliance and outcomes.

ARS Pharmaceuticals is dedicated to advancing treatments to better protect patients from severe allergic reactions. The company is developing neffy® (EURneffy in the EU) for use in emergencies involving food, medications, and insect bites that could lead to life-threatening anaphylaxis.

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