Gilead Sciences, Inc. GILD today 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 European Union (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, randomized studies in which Stribild met
its primary objective of non-inferiority compared to Atripla^® (efavirenz 600
mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 300 mg) (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,
United Kingdom. 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, diarrhea, 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.
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