Members / Guests FROM : Maraviroc Review Team THROUGH : Edward Cox
نویسنده
چکیده
The purpose of this document is to provide the Antiviral Products’ Advisory Committee with a summary of FDA analyses of data submitted in support of a request for accelerated approval of maraviroc, the first in a new class of antiretroviral drugs called CCR5 receptor antagonists. During the Advisory Committee meeting to be held on April 24, 2007, the Committee will be asked to consider the safety and efficacy data and provide comments regarding the following issues:
منابع مشابه
Hepatic safety of maraviroc in patients with HIV-1 and hepatitis C and/or B virus: 144-week results from a randomized, placebo-controlled trial.
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CYP3A5 plays a prominent role in the metabolism of maraviroc, an approved drug for human immunodeficiency virus (HIV)-1 treatment and a candidate for HIV-1 prevention. We studied the effect of the CYP3A5 genotype on pharmacokinetics of maraviroc and a primary CYP3A5-dependent metabolite of maraviroc denoted as metabolite 1 (M1). Volunteers were screened for health status and CYP3A5 genotype (wi...
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