GlaxoSmithKline Sees US Regulatory Therapy Submission by End of 2016
June 02 2016 - 2:42AM
Dow Jones News
LONDON--GlaxoSmithKline PLC (GSK.LN) Thursday said the
closed-triple combination therapy for patients with chronic
obstructive pulmonary disease application is expected to be filed
to the U.S. regulatory body by the end of 2016, rather than the
first half of 2018, as previously expected.
The healthcare company said it has made forward steps to filing
the application to the U.S. Food and Drug Administration, together
with and Innoviva Inc. (INVA).
The companies continue to expect an E.U. regulatory submission
of the therapy by the end of 2016, the company said.
Write to Olga Cotaga at olga.cotaga@wsj.com, Twitter
@OlgaCotaga
(END) Dow Jones Newswires
June 02, 2016 02:27 ET (06:27 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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