The US-based pharmaceutical company says it will continue its discussions with the FDA to address outstanding questions and finalize the product labeling as soon as possible.
Pfizer says that to date, more than 2,000 patients worldwide have received or are currently receiving treatment with maraviroc through clinical trials. Pfizer has also established an expanded access program (EAP) in 30 countries. The EAP is a clinical study that provides maraviroc in countries to patients who have limited treatment options prior to approval.
Pfizer is currently in the process of submitting marketing applications around the world to make maraviroc available globally.