The approval of EURneffy provides a new emergency treatment option for adults and children with anaphylaxis in the European Union.
RT’s Three Key Takeaways:
- Needle-Free Delivery: EURneffy is the first needle-free adrenaline treatment approved in the European Union for adults and children weighing at least 30 kg who experience severe allergic reactions.
- Improved Treatment Access: The nasal spray format addresses common barriers to adrenaline use, such as needle phobia and device complexity, which often lead to delays in emergency treatment.
- Clinical Validation: The European Commission’s decision was supported by a large development program that tested the 2 mg dose across various conditions, including nasal congestion and rhinitis.
The European Commission has approved EURneffy (adrenaline nasal spray) for the emergency treatment of severe allergic reactions, known as anaphylaxis, according to a news release from ARS Pharmaceuticals, Inc. The decision, announced August 22, 2024, introduces the first needle-free delivery method for adrenaline in the European Union (EU) in more than three decades.
The approval applies to adults and children weighing 30 kg or more. It follows a similar approval by the US Food and Drug Administration (FDA) on August 9, 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, in a news release. Muraro noted that many patients with severe allergies may not carry or may delay the use of injectable products.
The company stated that the needle-free format, smaller size, and longer shelf-life may increase the likelihood of patients carrying and administering the medication during an emergency. This delivery method aims to address safety concerns and improve access within the healthcare system for those at risk of anaphylaxis.
“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, in a news release.
The marketing authorization was based on data from a development program involving more than 700 study participants and over 1,200 administrations. Researchers evaluated the pharmacodynamics and pharmacokinetics of the 2 mg dose under various conditions, including repeat dosing, self-administration, and during nasal congestion or infectious rhinitis caused by a cold or flu.
Adrenaline autoinjectors are effective but often underutilized due to needle fear, lack of portability, and device complexity, according to the news release. ARS Pharma expects EURneffy to be available in certain EU member states by the fourth quarter of 2024.
