European Regulators Recommend Approval of Needle-Free Nasal Epinephrine Spray for Pediatric Anaphylaxis
核心洞察
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (搜索) has issued a positive recommendation for EURneffy 1 mg, a needle-free nasal adrenaline spray for treating anaphylaxis (搜索) in children aged 4 years and older weighing 15-30 kg.
This recommendation extends the existing marketing authorization for EURneffy 2 mg, which was approved in August 2024 for adults and children weighing 30 kg or more.
The approval addresses a significant medical need, as anaphylaxis (搜索) affects approximately 1 to 761 out of every 100,000 children annually in Europe, with food allergies (搜索) accounting for more than two-thirds of pediatric cases.
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (搜索) (CHMP) has adopted a positive opinion recommending marketing authorization for EURneffy 1 mg, a needle-free nasal adrenaline spray designed specifically for pediatric anaphylaxis (搜索) treatment. The recommendation covers emergency treatment of allergic reactions (搜索) in children aged 4 years and older with bodyweight between 15 kg and 30 kg.
Expanding Pediatric Treatment Options
The positive CHMP opinion represents an extension to the existing marketing authorization for EURneffy 2 mg, which the European Commission granted in August 2024 for emergency anaphylaxis (搜索) treatment in adults and children weighing 30 kg or more. This lower-dose formulation specifically addresses the treatment gap for younger children who require weight-appropriate dosing.
"We are delighted with the European health authorities' recommendation to grant the EURneffy 1 mg marketing authorisation which, if approved, will reinforce our paediatric focus by complementing the tablet approvals already obtained for treatment of children with respiratory allergy," said Henriette Mersebach, Executive Vice President of R&D at ALK. "EURneffy 1 mg has the potential to transform the lives of those living with or caring for children with severe allergic reactions (搜索), offering a needle-free, ready-to-use adrenaline solution."
Addressing Critical Medical Need
Anaphylaxis (搜索) represents the most severe form of allergic reaction and can be life-threatening, requiring immediate medical intervention. In Europe, the anaphylaxis incidence rate is approximately 1 to 761 out of every 100,000 children each year. Foods have emerged as the most common trigger of anaphylaxis in children, accounting for more than two-thirds of cases, with hospitalizations due to food allergies (搜索) in children continuing to increase.
The nasal spray is indicated for emergency treatment of allergic reactions (搜索) due to insect stings or bites, foods, medicinal products and other allergens, as well as idiopathic or exercise-induced anaphylaxis (搜索).
Regulatory Timeline and Market Access
The CHMP opinion will now undergo review by the European Commission. If granted, the marketing authorization is expected within the coming months and will be valid across all EU member states, as well as Iceland, Liechtenstein and Norway.
Strategic Partnership
The product, known as neffy in its original formulation, was developed by US-based ARS Pharmaceuticals, Inc. In November 2024, ALK entered into a strategic license agreement with ARS Pharmaceuticals, granting ALK exclusive global rights to commercialize neffy (including EURneffy in the EU) with exceptions for the USA, Australia, New Zealand, Japan, and China. The partnership was subsequently extended in May 2025 to include a co-promotion agreement in the USA.