FDA Approves Cabenuva for Adolescents with HIV

The FDA has approved Cabenuva (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment. Co-developed as part of a collaboration between Janssen and ViiV Healthcare, Cabenuva is the first long-acting HIV-1 treatment regimen, to be made available for eligible adolescents.

Cabenuva is approved as a once-monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. It contains ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine in a single-dose vial.

The expanded indication is supported by studies in adults and by data from the week 16 interim analysis of the ongoing More Options for Children and Adolescents (MOCHA) study from ViiV Healthcare’s collaboration with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT).

The efficacy in adolescents is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure. The safety profile in adolescents with the addition of either oral cabotegravir followed by injectable cabotegravir or oral rilpivirine followed by injectable rilpivirine was consistent with the safety profile established with cabotegravir plus rilpivirine in adults.

In January 2021, the FDA approved CABENUVA to be administered every month to adults living with HIV-1. In February 2022, the FDA approved an expanded label for CABENUVA to be administered every two months to adults living with HIV-1. The FDA approved a label update in March 2022 that made the oral lead-in period optional for adults living with HIV-1 who planned to begin the injectable treatment regimen. The oral lead-in period is also optional for adolescent patients.

Related:ViiV Healthcare Updates the Label for HIV-1 Med Cabenuva