Specialist HIV company ViiV Healthcare reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.

Cabenuva is provided as a co-pack with two injectable medicines -- ViiV Healthcare's cabotegravir and Janssen's rilpivirine -- dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.

Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy, ViiV Healthcare said.

The FDA's approval of Cabenuva is based on the pivotal phase III ATLAS and FLAIR studies, which included more than 1,100 patients from 16 countries. Cabenuva was as effective in maintaining viral suppression as continuing a daily oral three-drug regimen when injected intramuscularly once a month throughout the 48-week study period.

The company will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February 2021.

ViiV Healthcare is majority owned by GlaxoSmithKline plc (LON:GSK) (NYSE:GSK), with Pfizer Inc (NYSE:PFE) and Shionogi Limited as shareholders.