New HIV-focused drug gets approval by European regulator

GSK Plc said that its HIV-focused unit ViiV Healthcare’s cabotegravir long-acting injectable and tablets had received a recommendation for marketing authorisation from the European Medicines Agency’s human medicines committee.

Cabotegravir, is recommended in combination 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 kilogrammes, the company said.

GSK said the EMA’s Committee for Medicinal Products for Human Use’s (CHMP) positive opinion was based on results from studies in which the medicine, given as few as six times per year, demonstrated superior efficacy to a daily oral PrEP option in reducing the risk of HIV.

PrEP is an effective way for an at-risk HIV-negative person to reduce the risk of infection. But until recently, it was only available in pill form. GSK’s product is the first non-pill option. Cabotegravir, sold under brand name Apretude, is currently approved for use in the United States, Australia, Zimbabwe, South Africa, Malawi, Botswana and Brazil.

via Reuters