European Commission Approves Pfizer’s CCR5 Inhibitor MaravirocPfizer on Monday announced that the European Commission has approved its antiretroviral drug Celsentri, known generically as maraviroc, for sale and marketing in the European Union, Dow Jones/CNNMoney.com reports (Berton, Dow Jones/CNNMoney.com, 9/24). Maraviroc belongs to a new class of antiretrovirals that could provide an alternative to HIV-positive people who have developed resistance to multiple drugs. The treatment 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. FDA in August approved maraviroc on the condition that the drug's label include a black box warning about an increased risk of heart attack. FDA also is requiring Pfizer to conduct further research into the drug's long-term side effects (Kaiser Daily HIV/AIDS Report, 9/20). Maraviroc is sold under the brand-name Selzentry in the U.S. (Dow Jones/CNNMoney.com, 9/24).
According to a Pfizer release, the European Commission approved maraviroc based on 48-week data from two ongoing clinical trials (Pfizer release, 9/24). The data showed that nearly three times as many HIV-positive people who took maraviroc in combination with a traditional treatment regimen achieved undetectable levels of HIV, compared with those receiving only the traditional regimen. Pfizer also said that CD4+ T cell counts significantly were increased among people taking maraviroc, compared with participants who took only the standard regimen. Pfizer last week said the side effects recorded among participants who took maraviroc resembled those experienced by participants who received only the traditional regimen. The most common side effects reported included diarrhea, nausea, fatigue and headache (Kaiser Daily HIV/AIDS Report, 9/20).
"The approval of maraviroc will offer a new option to many people living with HIV in Europe," Filippo von Schloesser -- president of Fondazione Nadir Onlus, an Italian organization for people living with HIV/AIDS -- said, adding that "resistance to current treatments is one of the biggest challenges facing HIV care today" (Pfizer release, 9/24). This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.