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.”

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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.

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