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

(RTTNews) - GSK plc (GSK, GSK.L) announced Friday that the European Medicines Agency or EMA has validated the marketing authorisation application by its majority owned specialist HIV company ViiV Healthcare for cabotegravir long-acting injectable for HIV Prevention.

The company seeks approval of cabotegravir long-acting injectable for pre-exposure prophylaxis or 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 in reducing the risk of HIV acquisition.

The two phase IIb/III multicentre, randomised, double-blind, active controlled studies, HPTN 083 and HPTN 084, 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.

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

ViiV Healthcare is owned by GSK, along with Pfizer and Shionogi as shareholders.

For More Such Health News, visit rttnews.com