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EURneffy® approved as the first needle-free anaphylaxis treatment of adults and children in the UK
Globenewswire· 2025-07-18 12:01
Core Insights - The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved EURneffy 2 mg in the UK for the treatment of anaphylaxis in adults and children weighing 30 kg or more, with market launch expected soon after access negotiations [1][2][4] - EURneffy is the first approved adrenaline nasal spray for emergency treatment of anaphylaxis, potentially transforming the lives of patients with severe allergies in the UK, which is the largest anaphylaxis market in Europe [2][4] - The product features a needle-free design, longer shelf life of 30 months, and superior temperature stability compared to existing adrenaline auto-injectors, enhancing usability in emergency situations [3][4] Company Overview - ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma, headquartered in Hørsholm, Denmark, employing around 2,800 people and listed on Nasdaq Copenhagen [9] - The approval of EURneffy does not impact ALK's financial guidance for 2025, indicating stable financial expectations despite the new product introduction [6] Market Context - Anaphylaxis affects up to eight out of every 100,000 people annually in Europe, with one in 300 experiencing it at some point in their lives, highlighting the significant market need for effective treatment options [5] - The strategic license agreement with ARS Pharmaceuticals grants ALK exclusive global rights to commercialize neffy, excluding certain regions, and includes a co-promotion agreement in the USA [6]