(Alliance News) - GlaxoSmithKline PLC said on Tuesday its majority-owned specialist HIV company, ViiV Healthcare, had announced US Food & Drug Administration approval for use of Cabenuva in doses every two-months.
The FDA approval expands the label of the North Carolina-based ViiV Healthcare's long-acting HIV treatment, which can now be used every two months to treat HIV-1 in virologically suppressed adults. Cabenuva was first approved as a once-monthly treatment by the FDA in January of last year.
Cabenuva contains Viiv's cabotegravir extended-release injectable suspension in a single-dose vial, and rilpivirine extended-release injectable suspension in a single dose vial. Rilpivirine is a product of Janssen Sciences Ireland Unlimited Co, one of Janssen Pharmaceutical Companies of Johnson & Johnson.
GSK's shares were up 0.5% to 1,651.00 pence each in London on Tuesday afternoon.
Viiv Healthcare Head of North America Lynn Baxter commented: "Today's approval is a remarkable achievement given where HIV treatment was just a decade ago. We know some people living with HIV struggle with taking daily oral pills, and Cabenuva may allow them to maintain viral suppression while significantly reducing dosing to as few as six times a year."
Pfizer Inc and Shionogi & Co Ltd are also shareholders in Viiv Healthcare.
By Elizabeth Winter; elizabethwinter@alliancenews.com
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Glaxosmithkline (GSK)