European Advisory Panel Recommends Approval of Pfizer’s Antiretroviral Maraviroc, Company SaysPfizer on Thursday announced that the European Committee for Human Medicinal Products -- an advisory panel of the European Medicines Agency -- has recommended the sale and marketing of its antiretroviral drug maraviroc in the European Union, the AP/Houston Chronicle reports (AP/Houston Chronicle, 7/19).
Pfizer has proposed using the drug to treat people with advanced HIV or AIDS who have not responded to other medications. 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 plans to offer the drug with a test developed by Monogram Biosciences that determines if people are likely to respond to the treatment. Pfizer has proposed selling maraviroc under the brand name Celsentri. FDA last month issued an approvable letter for maraviroc. An approvable letter means that FDA believes the drug is worth approving but needs additional information before doing so. The company is in discussions with the agency to address outstanding questions and finalize the product labeling as soon as possible (Kaiser Daily HIV/AIDS Report, 6/21). CHMP said it recommended approval of maraviroc for use with other antiretrovirals among adults. EMA will make its final decision in the coming months, Reuters reports (Reuters, 7/19). This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.