The Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the 2-drug long-acting injectable regimen of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) for the treatment of HIV-1 infection in adults.
In the CRL, the FDA could not approve the NDA for reasons pertaining to Chemistry, Manufacturing and Controls (CMC). There have been no reported safety concerns related to the CMC and the CRL did not raise issues concerning safety data submitted as part of the application.
Data from 2 multicenter, open-label, parallel-group studies, ATLAS and FLAIR, were included in the NDA submission. The studies demonstrated that the 2-drug regimen administered by intramuscular injection every 4 weeks was noninferior to a standard of care 3-drug oral regimen in maintaining viral suppression in adults with HIV-1 infection (primary end point).
“We believe the once-monthly, long-acting regimen represents an important therapeutic advance for those living with HIV,” said Brian Woodfall, MD, Global Head, Development, Infectious Diseases, Janssen Biopharma, Inc. “We will continue to collaborate with our partners and the FDA to fully understand the requirements needed to support US approval as we continue in our efforts to change the course of the HIV epidemic.”
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.