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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