The FDA’s antiviral drugs advisory committee will meet April 24 to assess the safety and effectiveness of Pfizer’s first-in-class HIV therapy maraviroc, according to a posting to the agency’s Web site.
Maraviroc belongs to a class of drugs known as CCR5 antagonists, which block HIV from entering white blood cells through a pathway present in the majority of patients who carry the virus.
Pfizer plans to market maraviroc alongside a test developed by Monogram Biosciences that gauges whether patients are likely to respond to the treatment.
The twice-a-day maraviroc pill is designed to treat patients who have developed a resistance to other HIV drugs. There are roughly a million people in the US are HIV positive, according to Centers for Disease Control estimates.
News of the panel meeting on maraviroc came the same day as AIDS group, AIDS Healthcare Foundation (AHF), issued a statement banning Pfizer’s sales representatives from its treatment centers.
The organization issued a statement saying it believes that Pfizer’s “questionable marketing” of Viagra to treat erectile dysfunction, encourages recreational use of the drug and helps promote the spread of HIV and other sexually transmitted diseases.
AHF last month filed a lawsuit against Pfizer, alleging its consumer ads for Viagra were “false and misleading.”
Pfizer has denied the allegations in published reports.
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