BRIEF—FDA approves Cabenuva for use every two months

The US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir/rilpivirine) for every-two-month dosing for the treatment of 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.

Developed by GlaxoSmithKline majority-owned ViiV Healthcare, Cabenuva is the first and only complete long-acting HIV treatment regimen and was first approved by the FDA in January 2021 as a once-monthly treatment for HIV-1 in virologically suppressed adults. It contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of the Johnson & Johnson unit Janssen.

The FDA approval allows Cabenuva to be dosed monthly or every two months.