European Medicines Agency validates ViiV Healthcare’s marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced that the European Medicines Agency (EMA) has validated the company’s marketing authorisation application (MAA) seeking approval of cabotegravir long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1. Cabotegravir long-acting for HIV prevention is administered six times per year, after initiation.

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “With approximately 100,000 people in Europe newly diagnosed with HIV each year, this submission is an important step forward in offering expanded options for HIV prevention. Long-acting prevention options, if used appropriately and at scale, could have the potential to transform the shape of the HIV epidemic and we look forward to continuing to work with community groups, governments and regulatory authorities to make this option available for those who need it.”

Submission to the EMA was supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in HIV-negative men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV. The studies demonstrated that cabotegravir long-acting for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants experiencing a 69% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90% lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.

Cabotegravir long-acting for PrEP is currently approved in the US, Australia and Zimbabwe as Apretude.