Pfizer's Maraviroc to Receive Accelerated Regulatory Reviews in the U.S. and Europe
Pfizer announced that marketing authorization applications for maraviroc will receive accelerated review in both the United States and Europe. Accelerated reviews are granted to potential medicines that, if approved, 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 Research and Development. "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 U.S. Food and Drug Administration (FDA) priority review process takes place within a six-month period. Pfizer submitted the U.S. and EU maraviroc marketing applications in December 2006. 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.
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