GlaxoSmithKline Files Additional Trelegy Ellipta Application to FDA

By Dimitrios Kontos Features Dow Jones Newswires

GlaxoSmithKline PLC (GSK.LN) said Thursday that it has filed a supplemental new drug application with the U.S. Food and Drug Administration to support an expanded label for its inhaler Trelegy Ellipta.

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The application is to expand the treatment's indication so that physicians can use it to treat chronic obstructive pulmonary disease patients who require triple therapy, the company said.

The pharmaceutical company submitted data from its impact study which show the efficacy and safety of the treatment in a single inhaler, it said.

The treatment was approved for use in the U.S. in September for the long-term, once-daily, treatment of chronic obstructive pulmonary disease patients and, if approved, the supplemental new drug application would broaden this indication.

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

(END) Dow Jones Newswires

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November 23, 2017 02:48 ET (07:48 GMT)