Glaxo's ViiV Healthcare gets FDA approval for HIV treatment

The US Food and Drug Administration has approved ViiV Healthcare’s Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically-suppressed adults.

ViiV is majority-owned by GlaxoSmithKline, with Pfizer and Shionigi as shareholders. Glaxo said on Tuesday that the company’s treatment has been approved for administration as few as six times a year for virologically-suppressed adults living with HIV without prior treatment failure or resistance to cabotegravir or rilpivirine.

Glaxo noted that Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the US FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically-suppressed adults. It contains ViiV's cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial.

Lynn Baxter, head of North America at ViiV Healthcare, said: "ViiV Healthcare is pleased to continue our leadership in researching and developing long-acting innovative HIV treatment options that address the evolving needs of the HIV community.

"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."