Regeneron, Sanofi: EMA To Update Dupixent SmPC With Long-term Safety Data
Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNYNF,SNY) announced Monday that the European Medicines Agency will update the Dupixent (dupilumab) summary of product characteristics or SmPC. The agency will add 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 or CHMP.
The companies noted that data from a single-arm Phase 3 open label extension or 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 3 trials.
Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating. Dupixent is the only biologic approved in the European Union 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.
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 3 trial. The approved Dupixent dose in adults is 300 mg every other week.
Dupixent was invented using Regeneron’s proprietary VelocImmune technology. Dupixent is currently approved in more than 60 countries, and more than 260,000 patients have been treated globally.
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
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