US- ViiV’s Long-Acting Cabenuva (Cabotegravir, Rilpivirine) Approved for Virologically Suppressed Adolescents

ViiV announced that the FDA has approved Cabenuva (cabotegravir, rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 c/mL) who are 12 years of age or older and weigh at least 35kg on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. The regimen was co-developed as part of a 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.

Cabenuva is the first and only complete long-acting HIV treatment regimen and is approved as a once monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. Cabenuva 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.