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GEN News Highlights : Apr 25, 2007

FDA Advisory Committee Vouched Unanimously for Sanction of Pfizer’s HIV Medication

Maraviroc is under expedited regulatory review for treatment-experienced patients infected with CCR5-tropic HIV-1.

Pfizer reports that FDA’s Antiviral Drugs Advisory Committee voted unanimously (12-0) to recommend the approval of its HIV drug. If given the go ahead, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade, according to the company.

Maraviroc is a CCR5 antagonist and blocks the virus’ predominant entry route, the CCR5 co-receptor, thus preventing its entry into uninfected cells.

Pfizer has filed for approval of the drug to be used along with other antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1. The company still awaits final approval from FDA through an expedited regulatory review.

Pfizer says that it has a robust risk management plan for maraviroc through long-term follow up of ongoing clinical trials, pediatric studies, and pharmacovigilance, including a database study and a patient registry.