FDA Approves Cabenuva for HIV-1 Infection

FDA has approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for treating 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 active ingredient. An agency statement says Cabenuva is the first FDA-approved injectable complete regimen for HIV-infected adults that is administered once a month.

At the same time, FDA approved Vocabria (cabotegravir, tablet formulation) to be taken in combination with oral rilpivirine (Janssen’s Edurant) for one month before starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

FDA had granted Cabenuva and Vocabria fast track and priority review designations.