Policy & Politics
FDA Issues Approvable Letter for Pfizer's Antiretroviral Maraviroc
June 21, 2007
Pfizer in a statement released on Wednesday said it has received an approvable letter from FDA for its antiretroviral drug maraviroc, the Wall Street Journal reports. According to the Journal, 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, according to the statement (Corbett Dooren/Johnson, Wall Street Journal, 6/21).
Although FDA in April said it "continues to be concerned about potential safety issues with the entire class of drugs," some agency reviewers said they noted no increases in lymphomas or infections among people taking maraviroc. FDA reviewers have noted a "modest" increase in liver problems among people taking the drug. Pfizer has proposed selling maraviroc under the brand name Celsentri (Kaiser Daily HIV/AIDS Report, 6/8).
According to an unnamed Pfizer spokesperson, the company is working to answer the additional questions in the approvable letter, adding that the questions will not require new clinical trials (AP/Houston Chronicle, 6/20). The company did not elaborate on what questions were raised by FDA. It also did not give a new time line for FDA action, Dow Jones reports (Corbett Dooren, Dow Jones, 6/20). According to the Journal, because additional clinical trials are not needed, the drug could be available as soon as the third quarter of this year. Pfizer also has pledged to make maraviroc available to HIV-positive people in 30 countries through an access program, which is not affected by FDA's decision (Wall Street Journal, 6/21).
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.