Sanofi, Regeneron Dupixent gets approval in EU for expanded use in skin disorder
artJazz


The European Commission (EC) approved the expanded use of Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals' (NASDAQ:REGN) Dupixent (dupilumab) to treat adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.
PN is a chronic inflammatory skin disease in which itchy, rash appears usually on the arms, legs, upper back and/or the abdomen.

In November, a panel of the European Medicines Agency (EMA) had recommended issuing marketing authorization for the expanded use of Dupixent for treating PN.
The French drugmaker said that with this approval, Dupixent is the first and only targeted medicine specifically indicated to treat PN in Europe and the U.S.
The EC approval was backed by data from two phase 3 trials, called PRIME and PRIME2.
Dupixent is already indicated in the EU for conditions including atopic dermatitis and asthma.