FDA approves Cabenuva for virologically suppressed adolescents living with HIV

Updated: Apr 1

The approval marks the first time a long-acting HIV treatment is available for a younger population.

Yesterday, ViiV Healthcare announced that the US Food and Drug Administration (FDA) has approved Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents. The approval covers patients aged 12 years or older and weighing at least 35kg on a stable antiretroviral regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. The regimen was co-developed in collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson. “This approval marks the first time a long-acting HIV treatment is available for the adolescent population,” ViiV said in a statement as previous HIV treatment regimens required dosing every day. Cabenuva is the first and only complete long-acting HIV treatment regimen. It is approved as a once-monthly or every-two-months treatment.

The treatment is comprised of ViiV Healthcare’s extended-release injectable cabotegravir and Janssen’s extended-release injectable rilpivirine. These therapies are administered together in a single-dose vial. “Adolescents living with HIV and their caregivers face notable treatment challenges with daily oral HIV therapy, including the stress and difficulties of taking medication every day,” said Lynn Baxter, the head of ViiV Healthcare North America. “With today’s approval for Cabenuva, we are bringing this younger population a first-of-its-kind HIV treatment that is dosed as few as six times a year and removes the need for daily oral therapy altogether.” The expanded indication for Cabenuva is supported by studies in adults and data from the Week 16 interim analysis of the ongoing MOCHA study.