Sanofi and Regeneron seek new indication for Dupixent

8 March 2019

Sanofi (Euronext: SAN) has been granted Priority Review from the US Food and Drug Administration for its application to extend the label for Dupixent (dupilumab).

The French firm has filed for approval to market the therapy as an add-on maintenance treatment for certain adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP). The product is being developed in collaboration with Regeneron (Nasdaq: REGN).

The dual interleukin (IL)-4 and IL-13 blocker is approved in the USA for the treatment of certain adults with moderate-to-severe atopic dermatitis, as well as for the maintenance treatment of certain people with moderate-to-severe asthma.

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