Sanofi: FDA grants priority review for Dupixent

(CercleFinance.com) - Sanofi announces that the US FDA has agreed to grant priority review to Dupixent's application for an additional organic product license in the adjuvant maintenance treatment of moderate-to-severe atopic dermatitis of children aged six to 11 years old.


The French health group says that the test focuses on children who are inadequately controlled by topical treatments subject to medical prescription or for whom such treatments are not recommended. The FDA is set to make its decision on 26 May.

The sBLA application is based on a data set, for which the results of a pivotal Phase III clinical trial on the efficacy and safety of Dupixent, in combination with topical corticosteroids in children with severe atopic dermatitis.


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