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Pharmaceuticals / Submissions and Approvals

FDA Expands GSK Drug’s Approval to Rare Autoimmune Disorder

Dec. 18, 2017

GlaxoSmithKline secured expanded FDA approval for use of Nucala to treat the rare autoimmune disorder eosinophilic granulomatosis (EGPA), the first FDA therapy approved specifically to treat the disorder.

EGPA causes vasculitis, an inflammation in the wall of blood vessels, and is characterized by asthma and high levels of eosinophils, white blood cells that fight infections. The disease occurs at a rate of 10.7 to 14 per million adults.

The FDA granted the expanded approval under its priority review and orphan drug designations. GSK’s drug was previously approved in 2015 for an indication of severe asthma with an eosinophilic phenotype.

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