The FDA has issued an approvable letter for maraviroc, which is under review as a therapy for treatment-experienced patients infected with CCR5-tropic HIV-1.
Manufacturer Pfizer said it was continuing discussions with the FDA to address outstanding questions and finalise product labelling as soon as possible. Maraviroc is aimed at patients with HIV whose virus has become resistant to one or more currently available treatment options.
The company said to date, some 2,000 patients worldwide have received or are receiving treatment with maraviroc in 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 submitting marketing applications around the world.
Press release 20/7/2007