FDA Approves Pfizer's Antiretroviral Maraviroc
August 7, 2007
FDA on Monday approved Pfizer antiretroviral drug maraviroc, which belongs to a new class of antiretrovirals that could provide an alternative to HIV-positive people who have developed resistance to multiple drugs, the Los Angeles Times reports (Chong, Los Angeles Times, 8/7). FDA gave expedited approval of maraviroc for use in combination with other antiretrovirals (CQ HealthBeat, 8/6).
According to Debra Birnkrant, director of FDA's division of antiviral drug products, the approval comes after the agency concluded that HIV-positive people who have become resistant to other treatments need a new option. She added that FDA is requiring Pfizer to conduct further research into the drug's long-term side effects. According to Birnkrant, maraviroc is aimed at HIV-positive people who are quickly developing resistance to other available antiretrovirals and not people newly diagnosed as HIV-positive. For those people who are developing drug resistance to other treatments, maraviroc's "benefits clearly outweigh the risks," Birnkrant said, adding, "That doesn't mean there aren't any risks." According to a Pfizer spokesperson, maraviroc will be available in September and the wholesale cost will be about $900 monthly, the AP/Washington Post reports (Neergaard, AP/Washington Post, 8/6).
Helmut Albrecht, director of the University of South Carolina's Division of Infectious Diseases who was not involved with any maraviroc trials, said he was "cautiously optimistic" about the drug. He added, "It's so completely new that it is sort of difficult to see how well this is going to do over time." The last new class of antiretrovirals was approved by FDA in 2003.
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.