Regeneron, Sanofi announce CHMP opinion recommending Dupixent approval

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted an opinion recommending the approval of Dupixent in the European Union for the treatment of chronic spontaneous urticaria in adults and adolescents. This recommendation covers those aged 12 years and above with moderate-to-severe disease, with inadequate response to histamine-1 antihistamines and who are naive to anti-immunoglobulin E therapy. A final decision is expected in the coming months. The CHMP opinion is supported by data from two trials in the LIBERTY-CUPID Phase 3 program, both of which demonstrated Dupixent significantly reduced itch and hives at 24 weeks compared to placebo. A third trial from the LIBERTY-CUPID program, conducted in a different CSU patient population, provided additional safety data. The safety results of the trials were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent than placebo in the trials of adults and adolescents with CSU were injection site reaction, COVID-19, hypertension, CSU and accidental overdose.