The U.S. Food and Drug Administration has(FDA) approved maraviroc, an anti-retroviral drug for use in adults living with HIV, U.S. media reported Tuesday.
Maraviroc, sold under the trade name Selzentry, will be distributed by New York-based Pfizer Inc, marking the first in a new class of HIV medicines to enter the market designed to slow the advance of HIV.
Maraviroc is approved for use in combination with other anti-retroviral drugs to treat adults with CCR5-tropic HIV-1, who have been treated with other HIV medications and have evidence of elevated levels of HIV in their blood.
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.
Among patients who have previously received HIV medications, approximately 50 percent to 60 percent had circulating CCR5-tropic HIV-1.
"This is an important new product for many HIV-infected patients who have not responded to other treatments and have few options," said Steven Galson, director of FDA's Center for Drug Evaluation and Research.
The product label includes a boxed warning about liver toxicity and a statement in the Warnings/Precautions section about the possibility of heart attacks.
The FDA's approval of maraviroc is based on safety and effectiveness data from two double-blind, placebo-controlled studies. The 1,076 clinical trial participants were chosen because they still showed evidence of HIV-1 in their blood, despite taking other HIV medications.
The safety and effectiveness of maraviroc have not been established in adult and pediatric patients who have never been treated with any other HIV drug.
Source: Xinhua
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