TUESDAY, Aug. 7 (HealthDay News) -- The U.S. Food and Drug Administration has granted approval to Pfizer, Inc. to market the antiretroviral drug maraviroc, which will be sold under the trade name Selzentry. The drug is the first of a new class of drugs that combat the virus by blocking the CCR5 co-receptor on T cells.
The drug has been approved for use in a drug cocktail for adults with CCR5-tropic HIV-1 who still have an elevated viral load after treatment with other HIV medications.
Side-effects include cough, fever, upper respiratory tract infections, abdominal pain and dizziness. The drug also carries a boxed warning on hepatoxicity and a warning about the risk of myocardial infarction.
The FDA granted approval on the basis of two double-blind, placebo-controlled studies including 1,076 participants who met the criteria for drug treatment. The clinical trials did not seek to establish safety or efficacy in children or patients who had not received other HIV medication, or in women who are pregnant.
"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, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, in a statement.
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