LONDON, 20 Mar (APM) - ViiV Healthcare and Janssen's HIV combination treatment Cabenuva has been approved in Canada, the first country to authorise the once-monthly injection, it was announced on Friday.
Health Canada's approval follows a U.S. rejection of the combination of ViiV's experimental integrase inhibitor cabotegravir and Janssen's Edurant (rilpivirine) in December 2019 (APMHE 65626
The U.S. Food and Drug Administration questioned the treatment's chemistry, manufacturing and controls process, but not its safety. ViiV said on Friday it is working closely with the FDA to determine the appropriate next steps for the filing.
It said in a statement
that Cabenuva is the first once-monthly, complete long-acting therapy for treating HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed.
Vocabria (cabotegravir) oral tablets, with Canada also the first country to approve those, are to be used for short time periods in conjunction with Cabenuva.
Cabenuva allows virologically suppressed adults living with HIV to maintain viral suppression while reducing their dosing schedule from 365 days to 12 days a year, ViiV added.
Its chief executive Deborah Waterhouse said: "Today's approval marks a monumental step in the treatment of HIV and is a true testament to ViiV Healthcare's R&D innovation. 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 combination therapy is under review in Europe and in Switzerland and Australia. Further filings are planned in the coming months.
Canadian authorisation follows U.S. approval in April 2019 of ViiV's once-daily pill Dovato, a combination of dolutegravir and lamivudine, for use in newly diagnosed adults (APMHE 62592
). Dovato was approved in Europe in July last year. (APMHE 63562
ViiV is a joint venture between GlaxoSmithKline, Pfizer and Shionogi.