- 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.
For further details see:
Sanofi, Regeneron Dupixent gets EMA panel nod to treat eczema in kids under 5