GlaxoSmithKline: Submits New Drug Application to US Regulator for HIV Treatment
October 18 2018 - 11:51AM
Dow Jones News
By Maryam Cockar
GlaxoSmithKline PLC (GSK.LN) said Thursday that its subsidiary,
ViiV Healthcare Ltd., has submitted a new drug application to the
U.S. Food & Drug Administration for its HIV treatment.
The new drug application to the US regulator is for a
single-tablet, two-drug regimen of Dolutegravir and Lamivudine for
the treatment of HIV-1 infection.
In September Viiv Healthcare submitted a marketing authorization
application to the European Medicines Agency for Dolutegravir and
Lamivudine as a single-tablet, two-drug regimen for HIV and the
company expects approval in the coming months.
ViiV Healthcare is majority owned by GSK, with Pfizer Inc. (PFE)
and Shionogi & Co. Ltd. (4507.TO)
At 1513 GMT, GSK shares were up 20.20 pence, or 1.4%, at
1514.60
Write to Maryam Cockar at maryam.cockar@dowjones.com
(END) Dow Jones Newswires
October 18, 2018 11:36 ET (15:36 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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