United Kingdom-based ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for the investigational, monthly, injectable, two-drug regimen of cabotegravir and rilpivirine to treat HIV, it was reported yesterday.

The company has submitted a new drug application to the US FDA for the two-drug regimen to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. Cabotegravir, which is ViiV Healthcare's investigational integrase inhibitor, is not approved by regulatory authorities anywhere in the world. It is being developed for the treatment and prevention of HIV.

The application was submitted based on data from the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies, which assessed more than 1,100 patients from 16 countries. The studies indicated that 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, according to the company.