EU Regulators Recommend Approval of ALK-Abelló's EURneffy 1 mg Nasal Spray for Pediatric Anaphylaxis

Reuters
Jan 29
EU Regulators Recommend Approval of ALK-Abelló's EURneffy 1 mg Nasal Spray for Pediatric Anaphylaxis

ALK-Abelló A/S announced that the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency has adopted a positive opinion recommending the granting of marketing authorisation for EURneffy® 1 mg, a needle-free nasal adrenaline spray for the emergency treatment of anaphylaxis in children aged 4 years and older with a bodyweight between 15 kg and 30 kg. The CHMP opinion will be reviewed by the European Commission, with a decision on marketing authorisation expected in the coming months. If granted, the authorisation will be valid in all EU member states, as well as Iceland, Liechtenstein, and Norway. EURneffy® is developed by ARS Pharmaceuticals, Inc., which has granted ALK exclusive global rights to commercialise the product outside the USA, Australia, New Zealand, Japan, and China.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. ALK-Abelló A/S published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW1001161961-en) on January 29, 2026, and is solely responsible for the information contained therein.

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