First and Only Complete Long-Acting Injectable HIV Treatment

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.

“At Janssen, we are proud to continue advancing options that support patients and help healthcare providers in finding personalized treatment plans that address unique individual needs and circumstances for people living with HIV,” said Candice Long, President, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Products, LP. “Providing a diverse portfolio of HIV therapies is critical to help meet these various treatment needs, and we believe CABENUVA is a meaningful option for the patients and providers we serve.”

This U.S. FDA approval is based on the FLAIR (First Long-Acting Injectable Regimen) Week 124 results, which showed there were similar outcomes regarding maintenance of virologic suppression, safety, tolerability and pharmacokinetics in people starting cabotegravir and rilpivirine injections with or without the oral lead-in.