Regeneron Pharma: CHMP Adopts Positive Opinion For Dupixent

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi announced the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion for Dupixent, recommending expanded approval in the European Union to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy.

The positive CHMP opinion is supported by data from a Phase 3 trial in children 6 months to 5 years of age recently published in The Lancet, the company said.

In June 2022, Dupixent was approved by the FDA for children in this age group.

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