FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sanofi’s Dupixent Gets Priority Review

March 15, 2019

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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