EMA OKs expanded use of Regeneron/Sanofi's asthma med Dupixent in kids aged 6 to 11
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Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY)
announce that the EMA's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending to extend the approval of Dupixent (dupilumab) in European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation.

The positive opinion is supported by Phase 3 data showing that Dupixent added to 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 children with uncontrolled moderate-to-severe asthma.
The European Commission is expected to announce a final decision in coming months.
Dupixent is currently approved in Europe for adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation.
In October 2021, Dupixent was approved by the FDA as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma.