French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and above.

This recommendation targets patients with moderate to severe disease who have an inadequate response to H1 antihistamines and are naive to anti-IgE therapy, with a final EU decision expected in the coming months.

The CHMP opinion is supported by results from the LIBERTY-CUPID Phase 3 programme, in which Dupixent significantly reduced itch and hives at 24 weeks compared with placebo. Safety data from a third study confirmed a profile consistent with Dupixent's approved indications, with the most common adverse events including injection site reactions, COVID-19, hypertension, CSU, and accidental overdose.

Dupixent is already approved for CSU in certain adults and adolescents in Japan and the USA.

CSU is a chronic inflammatory skin condition driven in part by type 2 inflammation, causing recurrent hives and intense itch. Despite H1 antihistamine therapy, many patients experience uncontrolled symptoms that significantly impact quality of life.

If approved, Dupixent would be the first targeted therapy in over a decade indicated for CSU in the European Union, offering a new option for patients with limited alternatives.

Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.