Edurant + GSK 1265744 filed with FDA for HIV

ViiV Healthcare has submitted a New Drug Application (NDA) to the FDA seeking approval for the investigational, monthly, injectable, two-drug regimen of Edurant + GSK 1265744 (ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine) 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) pivotal phase III studies that included more than 1,100 patients from 16 countries and demonstrated the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a standard of care, daily, oral, three-drug regimen in maintaining viral suppression throughout the 48-week study period. These results were presented in March at the 2019 Conference on Retroviruses and Opportunistic Infections.

ViiV Healthcare and Janssen plan to submit regulatory applications for the two-drug regimen of cabotegravir and rilpivirine to the European Medicines Agency, Health Canada and other global agencies in the coming months. As part of the regulatory submission package to the FDA, ViiV Healthcare submitted a second NDA for an oral tablet formulation of cabotegravir that would be taken as an oral lead-in with an already-approved, once-daily, oral tablet formulation of rilpivirine.