French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Tuesday that the European Commission has approved Dupixent (dupilumab) for adults and adolescents aged 12 and older with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine therapy and are naive to anti-IgE treatment.

This approval is based on two phase 3 LIBERTY-CUPID studies which demonstrated that Dupixent significantly reduced itch and hives at 24 weeks compared with placebo. Safety data from the studies were consistent with Dupixent's known profile, with the most common adverse events including injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia.

The therapy can be used as a first-line targeted option for eligible CSU patients, providing a new treatment alternative for those with uncontrolled symptoms.

Approximately 270,000 people in the European Union live with CSU and continue to experience symptoms despite standard-of-care antihistamines.

Dupixent, which inhibits IL-4 and IL-13 -- central drivers of type 2 inflammation -- is now approved for seven chronic inflammatory diseases in the EU.

Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) and is approved in more than 60 countries for multiple type 2 inflammatory diseases.