Accelerated reviews are granted to potential medicines that would represent significant improvements over current therapies.
If approved by the regulatory agencies, maraviroc will 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.
“There is a profound global need for new medicines to help HIV/AIDS patients,” said John LaMattina, president, Pfizer Global R&D.
“We expect that CCR5 antagonists, like maraviroc, will become critically important new treatment options for patients who are resistant or intolerant to their current HIV/AIDS therapies.”
The FDA priority review process takes place within a six-month period. An FDA advisory panel is scheduled for April 24. Pfizer has begun pursuing regulatory approval for maraviroc in other countries to enable broad access to the drug.
In December 2006, Pfizer announced plans to establish a multi-national Expanded Access Program to provide maraviroc to patients with limited available treatment options based on its safety and efficacy observed in clinical trials to date.