Committee recommends approval of Pfizer AIDS drug

If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade. Maraviroc is a CCR5 antagonist, for use along with other antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1. The panel also suggested Pfizer should continue to study the drug to evaluate for potential risks.

Discovered by Pfizer scientists in 1997, maraviroc works by blocking viral entry to human cells. Rather than fighting HIV inside white blood cells, it prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

In trials, nearly twice as many treatment-experienced CCR5-tropic HIV-1 infected patients treated with maraviroc plus optimized background therapy (OBT) achieved undetectable viral loads at 24 weeks compared to those receiving placebo plus OBT.

Maraviroc is currently undergoing expedited regulatory review. While the FDA is not bound by the advisory committee recommendations, in most cases, the FDA does follow the recommendations.