The European Commission authorized the EURneffy 1 mg nasal spray for pediatric patients who weigh between 15 and 30 kg and are at risk of severe allergic reactions.
RT’s Three Key Takeaways:
- Needle-Free Administration: The European Commission granted marketing authorization for EURneffy 1 mg, the first nasal spray adrenaline treatment for children weighing 15 kg to 30 kg.
- Expanded Patient Access: This approval provides a non-invasive emergency option for children aged 4 and older at risk of severe allergic reactions from food, insect stings, and other allergens.
- Clinical Advantages: The nasal spray offers a 24-month shelf life, requires no priming, and is designed to overcome barriers such as needle phobia that can delay treatment during emergency situations.
ALK has received marketing authorization from the European Commission (EC) for EURneffy 1 mg, the first needle-free adrenaline treatment for young children at risk of severe allergic reactions, according to a news release.
The authorization applies to children aged 4 years and older with a bodyweight between 15 kg and 30 kg. The treatment is indicated for the emergency management of anaphylaxis caused by insect stings, foods, medicinal products, and other allergens, as well as idiopathic or exercise-induced reactions.
This approval expands the existing marketing authorization for EURneffy 2 mg, which the EC granted in August 2024 for adults and children weighing 30 kg or more.
Anaphylaxis is a life-threatening allergic reaction that affects between 1 and 761 out of every 100,000 children in Europe annually, the release stated. Food allergies are responsible for more than two-thirds of these cases.
“EURneffy 1 mg aims to address these barriers, offering an efficacious, needle-free, user-friendly adrenaline solution with the potential to transform the lives of those living with, or caring for, children with severe allergies,” said Flora Beiche-Scholz, executive vice president of commercial operations Europe at ALK, in a news release.
The nasal spray is absorbed through the nose and distributed into body tissues without the need for priming. It provides a portable, pocket-sized alternative to injectable adrenaline. The 1 mg dose has a shelf life of 24 months and requires no special storage conditions.
In the United States, the Food and Drug Administration (FDA) approved the 1 mg dose in 2025 under the brand name neffy for children weighing 15 kg to 30 kg. The treatment has also been approved in Japan, China, and the United Kingdom (UK).
The EC approval applies to all 27 European Union (EU) member states, Iceland, Norway, and Liechtenstein.
Image credit: Neffy via Finn Partners