ViiV Healthcare scores world-first approval in Canada for monthly HIV regimen Cabenuva

pharmafile | March 23, 2020 | News story | Sales and Marketing Cabenuva, Canada, HIV, pharma 

ViiV Healthcare has secured its first global approval for its once-monthly treatment Cabenuva, it has emerged, to replace current antiretroviral regimens for the treatment of HIV-1 infection in adult patients in Canada.

The approval issued by national regulator Health Canada concerns patients who are virologically stable and suppressed, as defined by HIV-1 RNA levels of less than 50 copies per millilitre. According to the specialist HIV firm ViiV, which is majority owned by GlaxoSmithKline and partly owned by Pfizer and Shionogi, Cabenuva is the “first and only once-monthly, complete long-acting regimen” for treatment of the disease.

The therapy, a combination of ViiV’s cabotegravir and Janssen’s reilpivirine, could mean huge things for virologically suppressed HIV patients who currently must rely on daily medication to remain healthy. With Cabenuva, ViiV says that these patients would only require treatment once a month and 12 days a year.

Alongside the approval, Health Canada also gave the first global authorisation to ViiV’s Vocabria oral tablets, to be used in conjunction with Cabenuva

The approval is based on Phase 3 data showing that, when injected into the buttocks on a monthly basis, Cabeunva was just as effective at maintaining viral suppression throughout the 48-week trial period as daily oral antiretroviral regimens.

“Cabenuva, an injectable treatment, has the potential to transform HIV care by offering monthly instead of daily treatment to suitable patients,” commented Dr Chloe Orkin, Consultant Physician and Clinical Professor at Queen Mary University of London and principal investigator in the Cabenuvca trials. “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.”

Cabenuva is currently awaiting regulatory review from the EMA and in Switzerland and Australia, with an FDA review currently in negotiation.

Matt Fellows

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