First intranasal anaphylaxis drug launches in Germany

An alternative to epinephrine autoinjectors that can be delivered by a nasal spray has been launched in Germany, its first market, by ALK-Abello.
Originally developed by ARS Pharma, the EURneffy product was approved by the European Commission in August 2024 for the emergency treatment of allergic reactions, including anaphylaxis, becoming the first needle-free option for the EU market.
It is an alternative to current pen injector formulations of epinephrine (adrenaline) like Viatris' EpiPen, ALK's own Jext product, and EmerAde that are approved for use in people who are experiencing potentially life-threatening allergic reactions in the EU.
According to ALK, EURneffy – which can be used for adults and children who weigh 30 kg or more – offers a longer shelf life (30 months) and superior temperature stability compared to existing adrenaline auto-injectors.
The Danish company licensed rights to EURneffy outside the US, China, Japan, and Australia/New Zealand from ARS last November for DKK 1 billion ($145 million) upfront and up to DKK 2.2 billion in regulatory and commercial milestones, plus royalties on sales.
It has predicted that the new product can achieve peak sales of almost $500 million a year, in its licensed markets, but said that the first launch will not affect its financial guidance for 2025.
"Physicians in Germany can now – as the first physicians in Europe – prescribe EURneffy as an easy-to-bring, user-friendly adrenaline treatment option for patients with life-threatening allergies," said Flora Beiche-Scholz, ALK's senior vice president of commercial operations in Europe.
"With EURneffy, we aspire to improve the lives of people with severe allergic reactions and facilitate that patients and caregivers consistently carry emergency medication."
In Europe, anaphylaxis occurs in up to eight out of every 100,000 people each year, and one in 300 people experiences it at some point in their lives. According to the EMA, some patients and caregivers delay or don't administer treatment in an emergency due to fear of the needle, lack of portability, or fear of people without medical training giving an injection.
ARS Pharma has launched the intranasal product in the US as neffy, after getting FDA approval at the second attempt, getting the green light in adults last summer and in children in March. The company reported $7.7 million in sales for the product in the first three months of 2025 in the US, where it is co-promoted by ALK.
Analysts at William Blair have previously suggested that the intranasal product could generate peak sales of around $750 million in the US alone.