Gilead Sciences, Inc. (Nasdaq: GILD) has announced that 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 Authorisation Application (MAA) for the once-daily, single tablet regimen Stribild® for the treatment of HIV-1 infection in adult patients who are antiretroviral-naïve or are infected with HIV-1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.
Stribild combines elvitegravir, an integrase inhibitor, and cobicistat, a pharmacoenhancing agent, with Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)). The CHMP’s positive recommendation will be reviewed by the European Commission, which has the authority to approve medicines for use in the 27 countries of the EU.
“With its potency, tolerability and convenient once-daily dosing, we believe Stribild has the potential to be an important treatment option for patients new to therapy or with no known resistance to any of the three components of the product,” said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead Sciences. “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.”
The regulatory filing for Stribild is supported by 48-week data from two Phase 3 double-blind, active-controlled, randomised studies in which Stribild met its primary objective of non-inferiority compared to Atripla® (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil (as fumarate) 300mg) (Study 102) and to a regimen containing ritonavir-boosted atazanavir plus Truvada (Study 103).
In November 2012, data from Studies 102 and 103 were presented at the 11th International Congress on Drug Therapy in HIV Infection in Glasgow, UK. These data demonstrated that Stribild maintained high antiviral efficacy through 96 weeks of treatment. In all studies, Stribild was well tolerated and most adverse events were mild to moderate. The most common adverse events observed were nausea, diarrhoea, upper respiratory tract infection and headache.
Stribild has received marketing approval in the United States, Canada, South Korea and Australia. To increase access to Stribild in the developing world, Gilead has granted its Indian manufacturing partners and the Medicines Patent Pool the right to develop and distribute generic versions of Stribild in 100 developing countries.
These agreements include a complete technology transfer from Gilead of the manufacturing process for the single tablet regimen.