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GSK GSK plc

45.06
-0.64 (-1.40%)
Last Updated: 16:31:46
Delayed by 15 minutes
Name Symbol Market Type
GSK plc NYSE:GSK NYSE Depository Receipt
  Price Change % Change Price High Price Low Price Open Price Traded Last Trade
  -0.64 -1.40% 45.06 45.20 44.945 45.12 868,153 16:31:46

GlaxoSmithKline Files Additional Trelegy Ellipta Application to FDA

23/11/2017 8:03am

Dow Jones News


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By Dimitrios Kontos

 

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.

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

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

Copyright (c) 2017 Dow Jones & Company, Inc.

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