The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Gilead Sciences' marketing authorization application (MAA) for stribild.
The once-daily, single tablet regimen is used to treat HIV-1 infection in adult patients who are antiretroviral-nave or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.
Stribild combines an integrase inhibitor, elvitegravir and a pharmacoenhancing agent, cobicistat with Truvada.
Gilead Sciences chairman and CEO John Martin said that the potency, tolerability and convenience of Stribild have the potential to be an important treatment for patients.
"We are pleased with today's positive opinion from the CHMP, and anticipate receiving a final decision from the European Commission on our application for Stribild in the coming months," Martin added.
Stribild has received marketing approval in the US, Canada, South Korea and Australia.
