Posted by Michael Wonder on 21 Jan 2021
FDA approves first extended release, injectable drug regimen for adults living with HIV
21 January 2021 - The U.S. FDA today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
This is the first FDA approved injectable, complete regimen for HIV infected adults that is administered once a month.
The safety and efficacy of Cabenuva were established through two randomised, open-label, controlled clinical trials in 1,182 HIV infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/mL) before initiation of treatment with Cabenuva.
