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sBLA for Dupixent Accepted by FDA for Priority Review

The sBLA is supported by data from a pivotal study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe bullous pemphigoid.

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By: Charlie Sternberg

Associate Editor

The US Food and Drug Administration (FDA) has accepted for priority review Regeneron and Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP), a chronic, debilitating, and relapsing skin disease with underlying type-2 inflammation that typically occurs in an elderly population Priority review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvement...

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