ViiV Healthcare : EMA Validates MAA For Cabotegravir Long-acting Injectable For HIV Prevention

(RTTNews) - ViiV Healthcare said that the European Medicines Agency or EMA has validated the company's marketing authorization application or 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.

The marketing application is based on results from the HPTN 083 and 084 phase IIb/III studies in which the injectable medicine, given as few as six times per year, demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition.

ViiV Healthcare is global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders.