The 1 mg dose of EURneffy is intended for emergency treatment of anaphylaxis in children weighing between 15 kg and 30 kg.
RT’s Three Key Takeaways:
- Pediatric Expansion: The Committee for Medicinal Products for Human Use (CHMP) recommended expanding the marketing authorization for EURneffy to include a 1 mg nasal adrenaline spray for children weighing between 15 kg and 30 kg.
- Needle-Free Alternative: If authorized by the European Commission, the product will be the first needle-free adrenaline option available for younger children in the European Union.
- Addressing Treatment Barriers: The nasal spray design aims to overcome barriers to timely administration, such as fear of needles and device complexity, which often lead to delays in emergency healthcare.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended expanding the marketing authorization for EURneffy (adrenaline nasal spray) to include a 1 mg dose, according to ARS Pharmaceuticals.
The recommendation covers the emergency treatment of Type 1 allergic reactions, including anaphylaxis, in children weighing between 15 kg and 30 kg. The indication includes reactions triggered by insect stings or bites, foods, medicinal products, and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
The CHMP opinion supports an extension to the EURneffy 2 mg approval granted by the European Commission in August 2024 for adults and children weighing 30 kg or more. Following the expected authorization of the 1 mg dose, the marketing authorization will be valid in all European Union member states, Iceland, Liechtenstein, and Norway.
“The availability of a needle-free adrenaline option for younger children directly addresses one of the most significant barriers to timely treatment in this age group,” said Richard Lowenthal, co-founder, president, and chief executive officer of ARS Pharma, in a news release.
Lowenthal noted that approximately one-quarter of epinephrine auto-injector use in Europe is for children weighing less than 30 kg. According to the news release, the needle-free design is intended to allow parents and caregivers to administer the treatment quickly and confidently.
The device is designed for portability and ease of use. It can withstand temperature excursions up to 50°C (122°F) and remains functional after thawing if accidentally frozen.
In the US, the spray is commercially available for the emergency treatment of allergic reactions in adults and children who weigh at least 33 pounds. In 2025, the 2 mg dose was launched in the UK and selected European countries. Regulatory decisions for the spray in Canada are expected in early 2026, following recent approvals in Japan, China, and Australia.
Type 1 allergic reactions are serious events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine. While auto-injectors are effective, limitations such as needle-related safety concerns, lack of portability, and device complexity often result in patients or caregivers delaying or avoiding treatment in an emergency, according to the news release.
