GSK announces European Commission authorized ViiV Healthcare’s Apretude

GSK (GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer (PFE) and Shionogi (SGIOY) as shareholders, announced that the European Commission has authorised Apretude for HIV prevention. Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents, weighing at least 35 kg. Cabotegravir LA injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year. This approval is supported by data from two international phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084. The studies demonstrated that cabotegravir LA for PrEP was superior to daily oral FTC/TDF tablets, with clinical trial participants given cabotegravir LA for PrEP 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.