ARS Pharmaceuticals’ EURneffy (Adrenaline Nasal Spray) Secures EC Approval
The European Commission has approved EURneffy®, the first and only needle-free adrenaline nasal spray, as an emergency treatment for allergic reactions, marking a historic advancement in anaphylaxis management for adults and children weighing over 30 kg.
Announced by ARS Pharmaceuticals, Inc. on the 26th of August, this approval represents the EU’s first new adrenaline delivery method in over three decades, providing a needle-free alternative for patients who have traditionally relied on injectable autoinjectors. The approval follows the U.S. Food and Drug Administration’s (FDA) green light on August 9, 2024, paving the way for EURneffy to launch in both major markets.
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) guidelines, underscored the importance of EURneffy’s innovative approach. Dr. Muraro stated:
“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. 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.”
ARS Pharmaceuticals Co-Founder, President, and CEO Richard Lowenthal emphasized the potential for EURneffy to redefine patient adherence and outcomes. He remarked:
“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. 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.”
Regulatory Journey and Development Data
The European Commission’s approval followed a rigorous review process grounded on Article 8(3) of Directive 2001/83/EC, involving one of the most extensive nasal spray development programs in pharmaceutical history. This included studies on over 700 participants and more than 1,200 administrations, with data covering pharmacodynamics, pharmacokinetics, and testing across various real-life dosing conditions, such as nasal congestion and cold/flu symptoms.
The newly granted approval also awards EURneffy an eight-year data exclusivity period, preventing other companies from using the submitted data, and a ten-year market exclusivity period. As a result, generic or biosimilar versions will be prohibited until 2039 under the current patent protections.
Addressing an Unmet Need in Anaphylaxis Treatment
Type I allergic reactions, including life-threatening anaphylaxis, are critical emergencies requiring immediate treatment. Injectable autoinjectors are currently the only approved adrenaline treatment in the EU. However, limitations such as needle fear, device complexity, and portability concerns have often led to delays in administering treatment, which can jeopardize patient outcomes.
While adrenaline autoinjectors have demonstrated effectiveness, “more than half [of patients] either delay or do not administer the device when needed in an emergency,” according to recent studies on autoinjector usage trends.
With commercialization in select European Union countries anticipated by the end of 2024, ARS Pharmaceuticals expects EURneffy’s introduction to change the landscape of emergency allergy treatment across the continent.
EURneffy is the trade name for neffy® (epinephrine nasal spray) in the European Union.
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