GlaxoSmithKline PLC (LON:GSK) said its ViiV Healthcare arm has received US Food & Drug Administration (FDA) approval for Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.
ViiV Healthcare is a specialist HIV company owned for the majority by GSK, but also has pharma giants Pfizer and Shionogi as shareholders.
READ: GlaxoSmithKline-owned ViiV Healthcare receives green light for long-acting HIV treatment
Cabenuva is provided as a co-pack with two injectable medicines, ViiV Healthcare's cabotegravir and Janssen's rilpivirine, dosed once monthly.
It is an option to replace the current antiretroviral regimen in those who have had their viral load reduced to undetectable levels and are on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine.
The FTSE 100 firm said patients should try one month of oral dosing of cabotegravir and rilpivirine to assess their tolerability before starting treatment with Cabenuva.
ViiV Healthcare will begin shipping Cabenuva to wholesalers and specialty distributors in the US in February.
"Today's FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care,” said Lynn Baxter, Head of North America at ViiV Healthcare, in a release.
“Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”