Summaries of health policy coverage from major news organizations
FDA Voices Concerns Over New HIV Drug Class
FDA said recently that it is concerned about a potential new class of HIV/AIDS drugs, called CCR5 inhibitors, that could be associated with an increased risk of liver damage, lymphoma and infections, the Wall Street Journal reports. FDA raised the concerns ahead of an advisory panel meeting scheduled for Tuesday to discuss Pfizer's CCR5 inhibitor maraviroc (Wall Street Journal, 4/21). 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 applied for FDA approval to market the drug, and an FDA advisory panel announced in February that it will meet on April 24 to examine the safety and efficacy of the drug. Pfizer plans to offer the drug with a test developed by Monogram Biosciences that determines if people likely will respond to the treatment (Kaiser Daily HIV/AIDS Report, 2/28). According to the AP/Washington Post, FDA has asked the panel whether maraviroc, if approved by the agency, would require special labeling. It also has asked the panel if additional studies of maraviroc's safety are needed before it can be sold or if the drug should be further studied among women and blacks. Pfizer has proposed selling maraviroc under the brand name Celsentri, the AP/Post reports (Bridges, AP/Washington Post, 4/20). According to FDA, other CCR5 inhibitors under development have been shown to increase the risk of safety issues, the Journal reports. Pfizer said its studies have shown that maraviroc has no significant effect on the heart and did not increase the incidence of liver problems, cancer or infection compared with other HIV/AIDS drugs (Wall Street Journal, 4/21). Although FDA "continues to be concerned about potential safety issues with the entire class of drugs," some agency reviewers have noted no increases in lymphomas or infections among people taking maraviroc, the AP/Post reports. FDA reviewers have noted a "modest" increase in liver problems among people taking the drug, according to the AP/Post (AP/Washington Post, 4/20).
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