
CHMP recommends Dupixent approval for asthmatic children aged 6-11 years
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sanofi and Regeneron’s Dupixent (Dupilumab) for asthmatic children aged 6 to 11 years with type 2 inflammation. The companies jointly announced that the European Agency’s recommendation has included the drug as an add-on maintenance treatment for children characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO). The add-on maintenance therapy is advised in children who are inadequately controlled on two maintenance therapies. The companies said that the new development comes amidst phase 3 data, recently published in the New England Journal of Medicine, which showed the efficacy of the drug in reducing asthma attack rates and exacerbations in patients.