ViiV Healthcare has today announced that Health Canada has approved Cabenuva (cabotegravir/rilpivirine), marking the first worldwide approval for the drug anywhere in the world.
In addition to the once-monthly, complete long-acting regimen, Canada has also approved Vocabria (cabotegravir) oral tablets, to be used for short time periods in conjunction with Cabenuva in the indication of HIV-1 infection.
The GlaxoSmithKline (GSK) company announced that the drug and combination have been approved for adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed, allowing virologically suppressed adults living with HIV to maintain viral suppression while reducing their dosing schedule from 365 days to 12 days per year.
GSK confirmed that the approval was based on the Phase III ATLAS and FLAIR studies, in which Cabenuva was as effective as continuing their daily, oral, antiretroviral regimens in maintaining viral suppression throughout the 48-week study period.
Further, Cabenuva was preferred over their previous daily oral therapy by approximately nine out of 10 patients who switched to cabotegravir and rilpivirine long-acting in ATLAS and FLAIR studies.
The approval “marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare’s R&D innovation,” commented Deborah Waterhouse, chief executive officer, ViiV Healthcare.
“With Cabenuva, people living with HIV who are virologically suppressed now have an option to maintain that suppression with 12 treatments a year thereby positively impacting their lives.”
The New England Journal of Medicine published the 48-week ATLAS and FLAIR results in its March 4, 2020 issue.