The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved a label update for Cabenuva (cabotegravir and rilpivirine), giving healthcare professionals and people living with human immunodeficiency virus (HIV-1) in the U.S. the option to start this once-monthly or every-two-month injectable treatment without the need for the oral lead-in phase (daily cabotegravir and rilpivirine tablets, taken for one month prior to initiation of cabotegravir and rilpivirine injections). Clinical data demonstrated the regimen displays a similar safety and efficacy profile both with and without an oral lead-in period. Cabenuva was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen's decades-long commitment to combatting HIV.

"We have a proven track record of bringing innovative therapies to people living with HIV, and our commitment to ushering in new scientific advancements has not wavered," said James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Development, LLC. "With this expanded label milestone, Janssen is offering an additional pathway that simplifies the treatment landscape for people living with HIV in the U.S. who are prescribed Cabenuva therapy."

Cabenuva is the first and only complete long-acting HIV treatment regimen and is approved in the U.S. as a once-monthly or every-two-month treatment for HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. 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.

Johnson & Johnson has been committed to the fight against HIV for decades, playing a central role in bringing nine different treatments to people living with HIV, and continuing to drive innovation in HIV prevention and care. Johnson & Johnson also works with vulnerable communities on the frontlines of the HIV epidemic through initiatives such as Positively Fearless, DREAMS Thina Abantu Abasha, the MenStar Coalition and the New Horizons Collaborative.