By IDSE News Staff
ViiV Healthcare submitted a New Drug Application (NDA) to the FDA seeking approval for the investigational, monthly, injectable two-drug regimen cabotegravir (ViiV) and rilpivirine (Janssen) to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) phase 3 studies that