GSK-Pfizer Backed HIV-Focused Unit ViiV Healthcare's Cabotegravir Injected Drug, Tablets Secure European Backing For Approval

ViiV Healthcare received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, recommending marketing authorization for cabotegravir long-acting (LA) injectable and tablets for HIV prevention. 

ViiV Healthcare is majority owned by GSK plc GSK, Pfizer Inc PFE, and Shionogi.

Cabotegravir is recommended with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents weighing at least 35 kg.

Approximately 100,000 new diagnoses each year. If approved, cabotegravir LA will be the only prevention option for people at risk of HIV acquisition, administered as few as six times yearly.

Also Read: GSK/Pfizer-Backed ViiV Healthcare's HIV Treatment At Par With Gilead's: Study Shows

The positive opinion is supported by data from two international phase 2b/3 studies, HPTN 083 and HPTN 084. 

The studies demonstrated that cabotegravir LA for PrEP was superior to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), with clinical trial participants given cabotegravir LA 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.

Price Action: GSK shares are down 0.73% at $35.49 during the premarket session on the last check Monday. PFE shares closed at $37.40 on Friday.