At present, ALK introduced that kids aged 4 and older dwelling with extreme allergic reactions throughout the EU can now entry the primary and solely needle-free adrenaline therapy for anaphylaxis, after the European Fee (EC) granted advertising and marketing authorisation for EURneffy® 1 mg – extending a category of therapy beforehand obtainable solely by injection.
EURneffy® 1 mg is now indicated for the emergency therapy of anaphylaxis resulting from insect stings or bites, meals, medicinal merchandise and different allergens, in addition to idiopathic or exercise-induced anaphylaxis in kids aged 4 years and older with a body weight between 15 kg and 30 kg. This approval extends the prevailing advertising and marketing authorisation for EURneffy® 2 mg, granted by the EC in August 2024 for the emergency therapy of anaphylaxis in adults and kids weighing ≥30 kg.1,2
Anaphylaxis – probably the most extreme, life‑threatening type of allergic response requiring rapid intervention – impacts an estimated 1 to 761 out of each 100,000 kids in Europe every year, with meals allergic reactions answerable for greater than two‑thirds of circumstances.3-5This approval means extra folks with extreme allergic reactions together with kids aged 4 years and older (≥15 kg) will probably be eligible for therapy with EURneffy®, the one needle-free adrenaline-based product at present permitted throughout the EU.
Flora Beiche-Scholz, EVP Industrial Operations Europe, ALK says: “This approval reflects our continued commitment to expanding treatment options for children with severe allergies. For decades, children at risk of anaphylaxis have been limited to injectable adrenaline – yet fear of needles, hesitancy to act and incorrect administration mean adrenaline is too often not carried or used in time. 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. This approval brings us closer to ensuring every family affected by severe allergies has a treatment they will actually carry and use.”
Medical proof and security profile
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EURneffy® offers fast absorption of adrenaline inside minutes of administration.2EURneffy® has a longtime security profile, primarily based on scientific knowledge from the EURneffy® growth programme involving over 700 contributors.2,6The commonest antagonistic reactions in topics weighing 15 kg to lower than 30 kg handled with EURneffy® 1 mg included: nasal congestion (19.0%), higher respiratory tract congestion (14.3%), dry throat, nasal dryness, and paraesthesia (every 9.5%).7There had been no clinically related variations within the security between the paediatric and grownup populations handled with EURneffy®.7EURneffy® 2 mg carried out in addition to conventional adrenaline auto-injectors or intramuscular adrenaline throughout a variety of real-world eventualities analyzing the scientific pharmacological impact together with single and repeat doses, self-administration, and conditions with nasal congestion from allergic reactions.2,8EURneffy® 1 mg dose demonstrated a comparable absorption and pharmacodynamic impact in kids (15-30 kg) as the two mg dose in kids and adults above 30 kg.6
This approval applies to all 27 European Union (EU) member states, Iceland, Norway and Liechtenstein.
ALK-Abelló A/S
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For additional info, please contact:
Media: Maiken Riise Andersen, tel. +45 5054 1434 Investor Relations: Per Plotnikof, tel. +45 4574 7527, cell +45 2261 2525
About EURneffy®EURneffy® is effectively absorbed by means of the nostril and distributed shortly into physique tissues, providing a conveyable, pocket-sized different to injectable types of adrenaline for treating extreme allergic reactions.1,2,9 EURneffy® has a complete shelf lifetime of 30 months (2 mg) and 24 months (1 mg), no particular storage necessities and freezing doesn’t have an effect on its shelf life.2,10 Upon activation, the EURneffy® nasal spray delivers a full, single dose of adrenaline, with out the necessity for priming.2
In the USA (US), Japan and China, EURneffy® 2 mg is permitted beneath the model identify neffy®. In 2025 the US Meals and Drug Administration (FDA) permitted neffy® 1 mg for the therapy of Sort I Allergic Reactions, together with anaphylaxis, in kids who’re aged 4 years and older and weigh 15–30 kg and Japan’s Prescribed drugs and Medical Units Company (PDMA) permitted neffy® 1 mg and a pair of mg doses for the emergency therapy of allergic reactions (anaphylaxis) in adults and kids who weigh ≥15 kg.10,11 EURneffy® / neffy® 2 mg has additionally been permitted by the UK’s Medicines and Healthcare Merchandise Regulatory Company (MHRA) and China’s Nationwide Medical Merchandise Administration (NMPA).12,13
ALK EURneffy 1 mg EU approval press launch.last
