EURneffy 1 mg approved across the EU as the first and only needle-free adrenaline treatment for young children (≥15 kg) at risk of anaphylaxis

Core Viewpoint - ALK has received marketing authorization from the European Commission for EURneffy 1 mg, a needle-free adrenaline treatment for anaphylaxis in children aged 4 and older, expanding treatment options for severe allergies across the EU [1][2][3] Group 1: Product Information - EURneffy 1 mg is indicated for emergency treatment of anaphylaxis due to various allergens in children weighing between 15 kg and 30 kg [2] - This approval extends the existing authorization for EURneffy 2 mg, which is for adults and children weighing 30 kg or more [2] - EURneffy is a portable, pocket-sized alternative to injectable adrenaline, with a shelf life of 30 months for 2 mg and 24 months for 1 mg, and does not require special storage [7] Group 2: Market Impact - The approval applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein, potentially increasing the market reach of ALK's products [5] - Anaphylaxis affects an estimated 1 to 761 out of every 100,000 children in Europe annually, with food allergies accounting for over two-thirds of cases, indicating a significant market need for effective treatments [3] Group 3: Clinical Evidence and Safety - EURneffy has a well-established safety profile based on clinical data from over 700 participants, with common adverse reactions including nasal congestion (19.0%) and upper respiratory tract congestion (14.3%) [8] - The 1 mg dose of EURneffy demonstrated comparable absorption and pharmacodynamic effects in children (15-30 kg) to the 2 mg dose in older children and adults [8] - EURneffy 2 mg has shown performance on par with traditional adrenaline auto-injectors in various real-world scenarios [8]