Sanofi: Dupixent obtains the positive opinion of the CHMP in severe asthma in children


PARIS (Agefi-Dow Jones)–The pharmaceutical company Sanofi announced on Monday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of Dupixent for the treatment of severe asthma associated with type 2 inflammation in children aged 6 to 11 years

The favorable CHMP opinion is based on phase 3 data published in the New England Journal of Medicine, which showed that Dupixent, in combination with standard asthma treatment, significantly reduced the number of severe asthma attacks. Within two weeks, this treatment also rapidly improves lung function, with sustained improvement for up to 52 weeks, in children with moderate to severe uncontrolled asthma.

The European Commission will review the CHMP recommendation and make a final decision on Dupixent’s marketing authorization application for this indication in the European Union in the coming months, Sanofi said in a statement.

Asthma is one of the most common diseases in children. Also up to 85% of children with asthma may have type 2 inflammation, which can increase the disease burden.

-Dimitri Delmond, Agefi-Dow Jones; +33 (0)1 41 27 47 31; [email protected] ed: XXX

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January 31, 2022 01:27 ET (06:27 GMT)



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