Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) said Friday the FDA approved Dupixent for treating chronic spontaneous urticaria in individuals aged 12 and up who continue to experience symptoms despite antihistamine use.

The approval follows phase 3 trials in which Dupixent, used alongside antihistamines, led to greater reductions in itching and hive activity compared to placebo, the companies said.

Patients given Dupixent were also more likely to achieve full or near-complete control of their condition after 24 weeks, Regeneron said.

The companies added that the reported side effects were consistent with the drug's existing safety profile, with injection site reactions being the most frequent.