U.S. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Only Long-Acting HIV Treatment

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....
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news