PFIZER'S MARAVIROC RECEIVES PRIORITY REVIEW IN THE U.S., EUROPE

Pfizer announced its application for the HIV drug maraviroc will receive accelerated review in the U.S. and Europe. Accelerated reviews are granted to drugs that, if approved, would represent significant improvements over current therapies, according to Pfizer.

Maraviroc would be the first in a new class of HIV/AIDS treatments called CCR5 antagonists that work by blocking viral entry. Rather than fighting HIV inside white blood cells, CCR5 antagonists prevent the virus produced by infected cells from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

The FDA priority review process takes place within a six-month period. Pfizer submitted the U.S. and European maraviroc applications in December 2006. An FDA advisory panel is scheduled to meet April 24 to discuss the application.

The marketing applications contain data from two pivotal Phase III trials. The trials, MOTIVATE-1 and 2, represent 24-week data comparing optimized background therapy, with or without maraviroc, in more than 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1.

In addition, Pfizer has established a multinational expanded access program to provide maraviroc to patients with limited treatment options.