02.13.07
Pfizer will receive accelerated review in both the U.S. and Europe for its marketing authorization applications for maraviroc. Accelerated reviews are granted to medicines that would potentially represent significant improvements over current therapies.
If approved, maraviroc would be the first in a new class of HIV/AIDS treatments called CCR5 antagonists that work by blocking viral entry. Instead of 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. Pfizer submitted the U.S. and EU maraviroc marketing applications in December 2006. An FDA Advisory Panel is scheduled for April 24. Pfizer is also pursuing regulatory approval for maraviroc in other countries.
If approved, maraviroc would be the first in a new class of HIV/AIDS treatments called CCR5 antagonists that work by blocking viral entry. Instead of 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. Pfizer submitted the U.S. and EU maraviroc marketing applications in December 2006. An FDA Advisory Panel is scheduled for April 24. Pfizer is also pursuing regulatory approval for maraviroc in other countries.