Posted by Michael Wonder on 21 Mar 2020
Janssen announces Health Canada approval of Cabenuva, the first long-acting regimen for the treatment of HIV
20 March 2020 - Cabenuva offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression.
Janssen announced that Health Canada has approved Cabenuva (cabotegravir and rilpivirine extended release injectable suspensions), the first and only once-monthly, long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per mL).
The approval of Cabenuva is based on the pivotal Phase 3 ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 patients from 16 countries.
