The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) has approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) 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 failure, nor known or suspected resistance to either cabotegravir or rilpivirine. Co-developed as part of a collaboration with ViiV Healthcare, CABENUVA is the first and only complete long-acting HIV-1 treatment regimen, and the first to be made available for eligible adolescents, building on Janssen’s ongoing commitment to fighting HIV and improving HIV treatment options for young people living with HIV.

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 extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Read more here.