FDA on Monday approved Pfizer's antiretroviral drug maraviroc, which belongs to a new class of antiretrovirals that could provide an alternative to HIV-positive people who have developed resistance to multiple drugs, the Los Angeles Times reports (Chong, Los Angeles Times, 8/7). FDA gave expedited approval of maraviroc for use in combination with other antiretrovirals (CQ HealthBeat, 8/6).
Maraviroc works by blocking a protein, called CCR5, on human immune system cells that HIV uses as a portal to enter and infect the cell. Pfizer has proposed using the drug to treat people with advanced HIV or AIDS who have not responded to other medications. Pfizer last month also announced that maraviroc can reduce HIV viral loads among people who have never taken antiretrovirals.
FDA approved maraviroc on the condition that the drug's label include a black-box warning -- the "strongest possible advisory" -- according to the Times. The drug also will have a warning about an increased risk of heart attack (Los Angeles Times, 8/7).
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