Gilead Sciences, Inc. (NASDAQ:GILD) today announced on 4/27/18 the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase class, emtricitabine or tenofovir.

“Triple therapy has been the standard of HIV treatment for more than 20 years and has allowed people living with HIV to achieve durable undetectability. At Gilead, we have continued to explore ways to improve and provide more HIV treatment options, with the goal of going beyond reducing viral load and helping to address some of the wider challenges faced by people living with HIV,” said Andrew Cheng, MD, PhD, Chief Medical Officer, Gilead Sciences. “If approved, Biktarvy would be the fifth TAF-based product for HIV in the European Union in the past three years, and because of its drug interaction profile, minimal monitoring requirements and ease of administration we believe it could represent a meaningful advance in HIV treatment for appropriate patients in Europe.”

The CHMP’s recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union, Norway, Iceland and Liechtenstein. A European Commission decision is expected in mid-2018.

Biktarvy was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018.