Cabenuva (cabotegravir and rilpivirine) granted approval by Health Canada
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) has been granted by Health Canada, in conjunction with use of Vocabria.
The first regulatory approval for Cabenuva (cabotegravir and rilpivirine) and Vocabria has been granted by Health Canada to ViiV Healthcare.
According to the company, Cabenuva is is the first and only once-monthly, complete long-acting regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed. Vocabria oral tablets are to be used for short time periods in conjunction with Cabenuva.
Cabenuva is administered intramuscularly as two individual injections in the buttocks of patients once a month by a healthcare provider.
Deborah Waterhouse, Chief Executive Officer of ViiV Healthcare, 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 approval of the drug is based on two Phase III studies that included more than 1,100 participants from 16 countries. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of T cells, a step essential in the HIV replication cycle and responsible for establishing chronic infection.
Cabotegravir and rilpivirine complete long-acting regimen for the treatment of HIV-1 infection therapy is under review by the European Medicines Agency (EMA) and regulatory authorities in Switzerland and Australia.