TITUSVILLE, N.J., February 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved an expanded label for CABENUVA (rilpivirine and cabotegravir) to be administered every two months for the treatment of HIV-1 in virologically suppressed adults (HIV-1 RNA less than 50 copies per milliliter [c/ml]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare and builds on Janssen’s 25-year commitment to make HIV history. ViiV Healthcare is the marketing authorization holder for CABENUVA in the U.S.

CABENUVA was approved by the U.S. FDA in January 2021 as a once-monthly, complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml).¹ CABENUVA is comprised of two separate injectable medicines, rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, and ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single dose vial. Prior to initiating treatment of CABENUVA, oral dosing of rilpivirine and cabotegravir should be administered for approximately one month to assess the tolerability of each therapy. The U.S. FDA Approval allows CABENUVA to be dosed monthly or every two months.

“The expanded label approval for CABENUVA—to be administered every two months—marks an important step forward in advancing the treatment landscape for people living with HIV,” said Candice Long, President, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Products, LP. “With this milestone, adults living with HIV have a treatment option that further reduces the frequency of medication.”

“An important goal for us in HIV is alleviating the need for daily medication, which can serve as a constant reminder for people living with the condition,” said James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Development, LLC. “With this new treatment option that reduces CABENUVA dosing frequency to just six times per year, we are revolutionizing HIV therapy for people living with HIV in the U.S.”

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