ViiV Healthcare, a company owned by GSK, Pfizer and Shionogi, has secured the Health Canada approval for CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) to treat a type of HIV-1 infection in adults.

CABENUVA has been approved as a long-acting regimen for the treatment of HIV-1 infection, replacing the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed.

In addition, VOCABRIA (cabotegravir oral tablets), designed to be used in conjunction with CABENUVA for short-term treatments, have also been approved by Health Canada.

ViiV Healthcare CEO 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.”

Health Canada granted first approval for CABENUVA and VOCABRIA to treat HIV-1

ViiV Healthcare has co-developed CABENUVA, by combining its cabotegravir and Janssen’s rilpivirine, through its collaboration with Janssen, leveraging its portfolio focused on delivering advanced medicines for the HIV community.

The phase-3 Antiretroviral Therapy as Long-Acting Suppression (ATLAS) and First Long-Acting Injectable Regimen (FLAIR) trials, which included more than 1,100 subjects enrolled from 16 countries, have supported the regulatory approval for CABENUVA.

The clinical trials showed that CABENUVA, injected intramuscularly, was as effective as daily, oral, antiretroviral regimens in maintaining viral suppression throughout the study period of 48 weeks.

In addition, both the studies demonstrated that injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhoea are the most common adverse reactions in participants receiving CABENUVA.

FLAIR study principal investigator Chloe Orkin said: “CABENUVA, an injectable treatment, has the potential to transform HIV care by offering monthly instead of daily treatment to suitable patients.

“It reduces the frequency of dosing and is as effective as daily, oral, three-drug regimens in maintaining viral suppression among adults living with HIV. Most participants in the clinical trials preferred it over their prior oral daily regimens.”

The European Medicines Agency (EMA) and regulatory authorities in Switzerland and Australia have been reviewing Cabotegravir and rilpivirine complete long-acting regimen for the treatment of HIV-1 infection therapy, and further regulatory authority submissions are planned in the coming months.

ViiV Healthcare said that it has been working together with the FDA to determine the possible next steps for a New Drug Application in the US.