Setting records every quarter, Dupixent drives growth at Sanofi

The US regulator has accepted for Priority Review a bid to broaden the label for Sanofi's (Euronext: SAN) monoclonal antibody Dupixent (dupilumab) in moderate-to-severe atopic dermatitis.

If approved, the new label will cover use as an add-on maintenance treatment for children aged six months to five years old, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

The target action date for a decision from the US Food and Drug Administration is June 9, 2022. Dupixent remains the only biologic medicine approved for patients six years of age and older in this indication.