Chmp recommends approval of dupixent® (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation

Tarrytown, n.y. and paris, jan. 31, 2022 /prnewswire/ -- recommendation based on pivotal trial that showed dupixent significantly reduced severe asthma attacks and improved lung function in children aged 6 to 11 years dupixent is the only biologic to show improved lung function in a randomized phase 3 trial for children data further reinforce well-established safety profile of dupixent regeneron pharmaceuticals, inc. (nasdaq: regn) and sanofi today announced that the european medicines agency's committee for medicinal products for human use (chmp) has adopted a positive opinion, recommending to extend the approval of dupixent® (dupilumab) in the european union (eu) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (feno) who are inadequately controlled on two maintenance therapies.
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