European Advisory Panel Recommends Approval of Pfizer's Antiretroviral Maraviroc
Pfizer's Antiretroviral Maraviroc
Pfizer 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).
Pfizerhas proposed using the drug to treat people with advanced HIV or AIDSwho have not responded to other medications. Maraviroc works byblocking a protein, called CCR5, on human immune system cells that HIVuses as a portal to enter and infect the cell. Pfizer plans to offerthe drug with a test developed by Monogram Biosciencesthat determines if people are likely to respond to the treatment.Pfizer has proposed selling maraviroc under the brand name Celsentri. FDAlast month issued an approval letter for maraviroc. An approvableletter means that FDA believes the drug is worth approving but needsadditional information before doing so. The company is in discussionswith the agency to address outstanding questions and finalize theproduct labeling as soon as possible (Kaiser Daily HIV/AIDS Report,6/21). CHMP said it recommended approval of maraviroc for use withother antiretrovirals among adults. EMA will make its final decision inthe coming months, Reuters reports (Reuters, 7/19).
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