FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sanofi’s Dupixent Gets Priority Review

March 15, 2019
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The FDA granted priority review status to Sanofi’s Dupixent (dupilumab) for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP).

There are no current FDA-approved biologics to treat the condition. The supplemental BLA is supported by data from two Phase 3 trials assessing its efficacy combined with standard corticosteroid nasal spray.

Dupixent is already approved for treatment of adults with moderate-to-severe eczema and for use with other asthma drugs for the maintenance treatment of moderate-to-severe asthma.

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