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GlaxoSmithKline's Nucala wins FDA approval for rare disease

GlaxoSmithKline plc won expanded approval from the U.S. Food and Drug Administration for its drug Nucala to treat patients with eosinophilic granulomatosis with polyangiitis.

Eosinophilic granulomatosis with polyangiitis is a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body.

Nucala is the first treatment approved by the agency for the disease, formerly known as Churg-Strauss syndrome.

The safety and efficacy of Nucala was based on data from clinical trial where patients taking the drug achieved a significantly greater accrued time in remission compared with placebo. Also, a significantly higher proportion of patients receiving Nucala achieved remission compared with placebo.

Nucala was first approved in 2015 to treat severe asthma with an eosinophilic phenotype.