FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi’s Dupixent Snags European Approval for Treating Severe Asthma

May 22, 2019
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The European Commission gave Sanofi’s biologic Dupixent (dupilumab) the greenlight for treating severe asthma for type 2 inflammation.

The agency approved the drug as an add-on maintenance treatment for severe asthma in patients 12 years and older with type 2 inflammation. The approval is for patients who aren’t adequately treated with high dose inhaled corticosteroids plus another drug product for maintenance treatment.

The drug “offers a new treatment option for those who remain inadequately controlled with current medications, including those dependent on oral corticosteroids,” said John Reed, Sanofi’s head of research and development.

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