ViiV Healthcare’s Cabenuva gets FDA nod for two-monthly use in HIV treatment

The latest approval expands the use of the first and only complete long-acting HIV treatment.

ViiV Healthcare, the HIV specialist company which is majority-owned by GSK announced several days ago that the Food and Drug Administration (FDA) had approved Cabenuva (cabotegravir, rilpivirine) for use every-two months to treat HIV-1 in virologically suppressed adults on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. The drug is ‘the first and only complete long-acting HIV treatment regimen and was initially approved by the FDA early last year for use as a once-monthly treatment for HIV-1 in virologically suppressed adults. With the latest FDA approval, Cabenuva can now be dosed either monthly or every two months. ViiV also counts Pfizer and Shionogi among its other shareholders.

According to a statement released by GSK, the drug’s contents include ‘cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, which is produced by one of J&J’s affiliate companies. “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,” said Lynn Baxter, Head of North America at ViiV Healthcare.