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FDA Approves Janssen’s CABENUVA

Becomes first and only once-monthly, long-acting regimen for the treatment of HIV infection.

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By: Kristin Brooks

Managing Editor, Contract Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson received aproval from U.S. FDA for CABENUVA (consisting of Janssen’s rilpivirine and ViiV Healthcare’s cabotegravir), the first and only once-monthly, long-acting regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults. The novel regimen was co-developed as part of a collaboration with ViiV Healthcare. In the U.S., ViiV Healthcare is the marketing authorization holder for CABENUVA.
 
CABENUVA is indicated as a 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) on a stable antiretroviral regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
 
CABENUVA, a co-packaged kit with two injectable medicines, offers people living with HIV a new approach for maintaining viral suppression.
 
The approval of CABENUVA is based on the Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 patients, demonstrating that CABENUVA was as effective as continuing a daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period.
UPS Healthcare

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