18th Oct 2018 16:47
LONDON (Alliance News) - GlaxoSmithKline PLC on Thursday said ViiV Healthcare has submitted a new drug application to the US Food & Drug Administration.
The submission covers a single-tablet, two-drug regimen of dolutegravir and lamivudine for the treatment of HIV.
ViiV Healthcare is a joint venture between American pharmaceutical firm Pfizer Inc and GlaxoSmithKline, created in November 2009.
The submission is based on the global phase III non-inferiority studies that included more than 1400 HIV-1 infected adults.
"We have now entered an exciting new era of treatments for people living with HIV," said ViiV Healthcare Chief Executive Deborah Waterhouse.
"This regulatory submission is the next step in the two-drug regimen journey and reinforces our belief that many patients can control their disease with two drugs instead of three or more," added Waterhouse.
Glaxo shares closed up 1.1% on Thursday at a price of 1,510.60.
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