Gilead's groundbreaking long-acting HIV therapy receives accelerated review in Europe.

Gilead Sciences, Inc. (GILD.US) announced today that the European Medicines Agency (EMA) has accepted the company's marketing authorization application (MAA) for lenacapavir, a once every six months injection for pre-exposure prophylaxis (PrEP) therapy for HIV infection. The EMA's Committee for Medicinal Products for Human Use (CHMP) considers the six-monthly administration of lenacapavir for HIV prevention to be of significant importance in public health and therapeutic innovation, and the marketing application will be evaluated on an accelerated assessment timeline. It is worth noting that last week the U.S. FDA announced that it has accepted Gilead Sciences, Inc.'s submission of a new drug application (NDA) for lenacapavir for PrEP and granted the application priority review status. The press release states that the decision by the EMA represents another regulatory milestone for lenacapavir as a PrEP therapy. The application submitted to the EMA is based on positive data from Gilead Sciences, Inc.'s Phase 3 clinical trials PURPOSE 1 and PURPOSE 2. In PURPOSE 1, data showed that female participants who received lenacapavir injections once every six months had no cases of HIV infection, resulting in a 100% reduction in the risk of infection compared to the background HIV incidence rates. In PURPOSE 2, 99.9% of participants in the lenacapavir treatment group remained uninfected with HIV, resulting in a 96% reduction in the risk of infection compared to the background HIV infection rates.