Dupilumab: latest news - GoINPHARMA
Tuesday, 26 March 2019 - 13:54

Dupilumab

MAA for Sanofi/Regeneron’s Dupixent accepted in Europe

Sanofi and Regeneron Pharmaceuticals announced that EMA accepted for review the MAA (Marketing Authorization Application) for Dupixent (dupilumab) for the treatment of adult patients with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent, an investigational product, is a…

FDA, priority review for Sanofi/Regeneron’s dupilumab in atopic dermatitis

Sanofi and Regeneron Pharmaceuticals today announced that FDA has accepted for priority review the BLA (Biologics License Application) for dupilumab for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The PDUFA (Prescription Drug User Fee Act) should…