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.
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The new indication represents the third one for Sanofi/Regeneron's IL-4/IL-13 inhibitor, after atopic dermatitis and moderate to severe asthma.
The latest drug development news and highlights from our US FDA Performance Tracker.
Dermira hopes to move into Phase III quickly with IL-13 inhibitor lebrikizumab, looking at monthly dosing in the maintenance setting. Efficacy in Phase IIb appears similar to Sanofi/Regeneron’s Dupixent.