Dupixent Approved For Severe Asthma With Broader Label Than Other Biologics

The US FDA cleared Sanofi/Regeneron's IL-4/IL-13 inhibitor for moderate-to-severe asthma in patients with an eosinophilic phenotype or with oral corticosteroid-dependent asthma, a broader label than AstraZeneca's Fasenra, GSK's Nucala and Teva's Cinqair.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.

Sanofi/Regeneron Pharmaceuticals Inc.'s IL-4/IL-13 inhibitor Dupixent (dupilumab) was approved by the US FDA for a new indication, moderate-to-severe asthma, with a broad label that will make the treatment tough new competition for other biologics approved for severe asthma.

The FDA approved Dupixent Oct. 19 as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and...

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