CHMP Backs Sanofi-Regeneron's Dupixent For Asthma Patients Aged 6 - 11 Years With Type 2 Inflammation

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending expanding the use of Dupixent (dupilumab).

• The positive opinion covers Dupixent as an add-on maintenance treatment for severe asthma children aged 6 to 11 years with type 2 inflammation who are inadequately controlled on two maintenance therapies. 
• The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
• Related: Regeneron, Sanofi Withdraw FDA Application For Libtayo's Expanded Use.
• Sanofi SA SNY and Regeneron Pharmaceutical Inc REGN are developing Dupilumab under a global collaboration agreement.
• The CHMP positive opinion is supported by Phase 3 data showing that Dupixent added to the standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks. 
• In October, the FDA approved Dupixent as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or oral corticosteroid-dependent asthma. 
• Price Action: REGN shares closed 2.66% higher at $624.92, while SNY stock closed at $52.74 on Friday.