Dupixent receives first-in-decade EU approval in chronic spontaneous urticaria

Following US approval in April of the first new targeted treatment for chronic spontaneous urticaria (CSU) in a decade, the European Commission (EC) has now authorised the same therapy for eligible EU patients.

Sanofi and Regeneron’s Dupixent (dupilumab) is available as a first-line option for moderate-to-severe CSU in individuals 12 years old and over. Specifically, it is indicated for those with inadequate response to histamine-1 antihistamines (H1AH) and who are naive to anti- immunoglobulin-E (IgE) therapy.

Dr George Yancopoulos, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron, explained that Dupixent is “the only treatment that inhibits IL4 and IL13, two key drivers of type 2 inflammation, and can offer patients significant improvement in debilitating itch and hives. This approval further demonstrates the ability of Dupixent to advance the treatment landscape for yet another chronic type 2 inflammatory disease, with a well-established safety profile across its indications.”

Clinical evidence of efficacy of Dupixent in chronic spontaneous urticaria 

The European Commission (EC)’s decision was based on data from two phase III clinical studies (Study A and Study C) in the LIBERTY-CUPID programme, which overall evaluated 284 patients.

Both studies assessed Dupixent as an adjunct therapy to standard-of-care antihistamines compared to only antihistamine treatment.

Dr Alyssa Johnsen, PhD, Global Therapeutic Area Head, Immunology Development at Sanofi stated that Dupixent “led to more patients experiencing well-controlled disease or a complete response compared to placebo in two phase III studies.”

Dupixent is also approved for CSU in countries including the US, and in the EU for paediatric patients with eosinophilic esophagitis.

As for dupilumab’s potential in other type 2 inflammation-driven or allergic diseases, the biologic is being evaluated in phase III studies in chronic pruritus of unknown origin, lichen simplex chronicus, and allergic fungal rhinosinusitis, according to Sanofi.