Priority review for Dupixent sBLA in children with eczema

The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for a children’s eczema indication.

Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals' (NASDAQ: REGN) monoclonal antibody would be the first biologic approved in the USA for children in this indication, for use as an add-on maintenance treatment for those aged six to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The target action date for the FDA decision is May 26 of this year. The agency granted Dupixent Breakthrough Therapy designation for the treatment of severe atopic dermatitis who are not well controlled on topical prescription medications, in 2016.