FDA approves antiretroviral drug
August 7, 2007The U.S. Food and Drug Administration has approved the antiretroviral drug maraviroc for use in adult human immunodeficiency virus patients.
The FDA said maraviroc, sold under the trade name Selzentry, is the first in a new class of drugs designed to slow the advancement of HIV.
Maraviroc is approved for use in combination with other antiretroviral drugs for the treatment of adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood, the FDA said.
Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering uninfected cells by blocking the predominant route of entry -- the CCR5 co-receptor. CCR5 is a protein on the surface of some types of immune cells.
"This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
The product label includes a boxed warning about liver toxicity -- hepatoxicity -- and a statement about the possibility of heart attacks.
Maraviroc is distributed by Pfizer Inc.
Copyright 2007 by United Press International
Oct 01, 2008 |
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