ViiV Healthcare, a GlaxoSmithKline (GSK) company focused on HIV treatment, has secured the US Food and Drug Administration (FDA) approval for Cabenuva to treat HIV-1 infection in adults.

Cabenuva is an injectable formulation containing ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine, dosed once monthly.

The FDA approval indicated the drug as an option to replace the current antiretroviral (ARV) regimen in people who are virologically suppressed on a stable regimen, with no history of treatment failure, and resistance to either cabotegravir or rilpivirine.

The US regulator also mandated oral dosing of cabotegravir and rilpivirine for around one month to assess the tolerability of each therapy, before commencing the treatment using Cabenuva.

The company said that its Cabenuva is the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults.

ViiV Healthcare North America head Lynn Baxter said: “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.

“Cabenuva reduces the treatment dosing days from 365 days to 12 days per year. At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”

The US FDA approval of Cabenuva is supported by the Phase 3 Antiretroviral Therapy as Long-Acting Suppression (ATLAS) and First Long-Acting Injectable Regimen (FLAIR) studies in more than 1,100 patients from 16 countries.

Oral dosing of cabotegravir and rilpivirine was administered in the studies, for nearly one month to evaluate the tolerability of each therapy, before the treatment using Cabenuva.

In the studies, treatment using Cabenuva demonstrated similar effects on the maintenance of viral suppression as a daily oral three-drug regimen, when injected intramuscularly in the buttocks once a month for 48 weeks.

FDA Centre for Drug Evaluation and Research Office of Infectious Diseases director John Farley said: “Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition.

“This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen. Having this treatment available for some patients provides an alternative for managing this chronic condition.”