ViiV Healthcare has submitted a New Drug Submission (NDS) to Health Canada for the investigational long-acting (LA) injectable and tablets of cabotegravir for PrEP. This submission is currently undergoing review under the Priority Review Policy.
If approved, cabotegravir would mark the first long-acting therapy available in Canada for PrEP, aimed at reducing the risk of sexually acquired HIV-1 infection among HIV-negative individuals at risk for HIV.
Health Canada assigns Priority Review status to drug submissions intended for treating, preventing, or diagnosing serious, life-threatening, or severely debilitating illnesses. This designation is granted when there is substantial evidence of clinical effectiveness, addressing an unmet medical need or providing an improved benefit/risk profile over existing therapies.
Following approvals in the U.S., Australia, Brazil, South Africa, the European Union, and other countries, Canada's regulatory submission is in progress. The NDS incorporates data from pivotal phase IIb/III studies, HPTN 083 and HPTN 084, demonstrating the superiority of cabotegravir long-acting for PrEP over daily oral FTC/TDF tablets. Participants experienced a 69% lower rate of HIV acquisition in HPTN 083 and a 90% lower rate in HPTN 084 compared to FTC/TDF tablets.