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# Janssen Gets Expanded Label for HIV-treating Cabenuva
- URL: https://www.fdaweb.com/janssen-gets-expanded-label-for-hiv-treating-cabenuva/
- Published: 2022-02-02T12:00:00.000Z
- Updated: 2026-09-14T17:30:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151063

FDA has approved a Janssen Pharmaceutical expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two months for treating HIV-1 in virologically suppressed adults with no history of treatment failure, and with no known or suspected resistance to either rilpivirine or cabotegravir. Cabenuva was [approved](https://www.jnj.com/janssen-announces-u-s-fda-approval-of-cabenuva-rilpivirine-and-cabotegravir-the-first-long-acting-regimen-for-the-treatment-of-hiv?ref=fdaweb.com) 1/2021 as a once-monthly, complete regimen for treating HIV-1 infection in adults to replace their current antiretroviral regimen after becoming virologically suppressed. It comprises two separate injectable medicines — Janssen’s rilpivirine extended-release injectable suspension in a single-dose vial and ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial.

Approval was based on data from the global ATLAS-2M Phase 3b trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing, according to the company. The study also found that rates of virologic suppression, a key secondary endpoint, were similar for once-every-two-months and once-monthly dosing.