Dupixent product characteristics updated with long-term data reinforcing well-established safety profile in adults with moderate-to-severe atopic dermatitis – Regeneron + Sanofi

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency will update the Dupixent (dupilumab) summary of product characteristics (SmPC) adding long-term safety results for adults with moderate-to-severe atopic dermatitis based on a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).

Data from a single-arm Phase III open label extension (OLE) trial showed the long-term safety profile in adults with atopic dermatitis observed up to three years was generally consistent with what was observed in the controlled pivotal Phase III trials.

The OLE trial assessed the long-term safety of Dupixent 300 mg weekly in adults who had previously participated in controlled Dupixent trials or had been screened for a Phase III trial. The approved Dupixent dose in adults is 300 mg every other week.

Dupixent is the only biologic approved in the European Union (EU) for children as young as six years with severe atopic dermatitis, as well as for adolescents and adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.