GlaxoSmithKline's Nucala gets FDA Approval for EGPA

By FeaturesDow Jones Newswires

GlaxoSmithKline PLC (GSK.LN) said on Tuesday that its drug Nucala has been given approval by the Food and Drug Administration for the treatment of eosinophilic granulomatosis with polyangiitis, previously known as Churg-Strauss syndrome, in the U.S.

Nucala was first approved in 2015 for severe eosinophilic asthma and the company submitted a supplemental application in June 2017, to expand the use of the medicine.

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The company said that the FDA's approval is based on results from a 52-week, phase 3 study which was conducted as a collaboration between GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases.

Write to Dimitrios Kontos at dimitrios.kontos@dowjones.com

(END) Dow Jones Newswires

December 12, 2017 11:54 ET (16:54 GMT)