ViiV Healthcare files for US approval of HIV combo regimen

Global specialist HIV company ViiV Healthcare, majority owned by GlaxoSmithKline (LSE: GSK), has submitted a New Drug Application (NDA) to the US Food and Drug Administration seeking approval for the investigational, monthly, injectable, two-drug regimen of 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.