FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi Wins European Approval for Asthma Biologic

May 16, 2019
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The European Commission approved Sanofi’s Dupixent (dupilumab) for severe asthma, the first biologic of its kind to win the European authority’s approval.

Dupixent is now approved for patients 12 years or older with type 2 inflammation for whom inhaled steroids are note effective.

The greenlight comes after Sanofi presented positive data on 2,888 patients from three pivotal trials as part of its Liberty Asthma program.

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