NDA for Once-Monthly Injectable HIV Treatment Submitted to FDA

The New Drug Application (NDA) for the long-acting injectable formulation of rilpivirine + cabotegravir (Janssen and ViiV Healthcare) for patients with HIV-1 infection has been submitted to the Food and Drug Administration (FDA).

The NDA submission was based on data from 2 multicenter, open-label, parallel-group studies (ATLAS and FLAIR) which demonstrated that the 2-drug regimen administered by intramuscular injection every 4 weeks was non-inferior to a standard of care 3-drug oral regimen in maintaining viral suppression in adults with HIV-1 infection (primary endpoint), as measured by the proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48. In both studies, virologic suppression rates (HIV-1 RNA <50 copies/mL) were found to be similar between the 2 treatment arms at Week 48.

Commenting on the NDA submission, Brian Woodfall, MD, Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. said, “We believe this once-monthly injectable regimen has the potential to offer many people living with HIV a treatment option that does not require taking pills every day.”

Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is currently approved in an oral formulation to treat HIV-1 in combination with other antiretrovirals, while cabotegravir is an investigational integrase inhibitor. In addition to the NDA for the injectable formulation, a second NDA for an oral form of cabotegravir has also been submitted for review for treatment in combination with oral rilpivirine.

For more information visit viivhealthcare.com or janssen.com.

This article originally appeared on MPR