Achieving U.S. Food and Drug Administration priority review status for its New Drug Application (NDA), Gilead Sciences Inc. recently made strides towards realizing an investigational, fixed-dose product combining several drugs to address HIV-1 infection.
The product consists of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, according to Gilead spokespersons.
The company filed its NDA for the mixture, referred to as BIC/FTC/TAF, in mid-June; the FDA anticipates a target action date of Feb. 12, 2018. The potential product was informed by four different studies, and a European version of the application is also underway, with BIC/FTC/TAF validated by the European Medicines Agency (EMA) in July.
Ready for review in tablet form, the treatment is still considered investigational and still awaits official approval worldwide.
Based in Foster City, California, Gilead is a research-based biopharmaceutical company focused on developing and marketing innovative medicines. The firm has worked towards breakthroughs in HIV treatment, prevention, testing and research for almost 30 years.
Over 10 million individuals living with HIV are estimated to be receiving antiretroviral treatment developed by Gilead and/or its manufacturing affiliates, according to the company. Gilead strives to advance the care of patients suffering from life-threatening diseases.