Sanofi, Regeneron Dupixent gets EMA panel nod to treat eczema in kids under 5
RomanBabakin


A committee of the European Medicines Agency (EMA) recommended granting expanded approval to Sanofi (NASDAQ:SNY) and Regeneron Pharmaceuticals (NASDAQ:REGN) Dupixent to treat severe atopic dermatitis (eczema) in children six months to five years old who are eligible for systemic therapy.
The positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP) was backed by data from a phase 3 trial which showed Dupixent improved skin clearance and reduced disease severity, Sanofi said in a press release on Friday.

The European Commission, which generally follows the opinion of the CHMP, is is expected to make a final decision on the application in the coming months.
The French pharma giant said that if approved, Dupixent (dupilumab) would be the first and only targeted medicine in the EU for these young children.
Dupixent is already approved in the EU for to treat certain patients with including, prurigo nodularis, atopic dermatitis, asthma, among others.