GlaxoSmithKline Files Additional Trelegy Ellipta Application to FDA
23 Noviembre 2017 - 2:03AM
Noticias Dow Jones
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)
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