RTTNews | Jan 31, 2022 01:29AM EST

01:28 Monday, January 31, 2022 (RTTNews.com) - The European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion, recommending to extend the approval of Dupixent or dupilumab in the European Union 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 who are inadequately controlled on two maintenance therapies, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said in a statement on Monday.

The European Commission is expected to announce a final decision on the Dupixent application in the coming months.

The recommendation was 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, the companies said.

On October 20, 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 characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved.

Read the original article on RTTNews ( https://www.rttnews.com/3258489/sanofi-chmp-recommends-approval-of-dupixent-for-children-with-severe-asthma-with-type2-inflammation.aspx)

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