Drug company Pfizer has said that its marketing authorisations for the HIV treatment maraviroc will receive an accelerated review from regulators in both the United States and the European Union.
The firm said that if maraviroc is passed by the regulatory agencies, it will be the first drug approved in a new class of HIV/AIDS treatments – CCR5 antagonists – which work by blocking viral entry. Instead of fighting HIV inside white blood cells, the new antagonists prevent virus produced by infected cells from entering uninfected cells, by blocking the main entry route – the CCR5 co-receptor.
The US Food and Drug Administration’s priority review process takes place within a six-month period and as Pfizer submitted both marketing applications in December 2006, it expects to hear from an agency advisory panel on or before April 24. Regulatory approval for maraviroc is also being sought in other countries.
Pfizer R&D president John LaMattina said “there is a profound global need for new medicines to help HIV/AIDS patients”, and CCR5 antagonists “will become critically important new treatment options for patients who are resistant or intolerant to current therapies”.
The marketing applications for maraviroc were based on Pfizer’s review of efficacy and safety data from two pivotal Phase III trials – MOTIVATE-1 and 2, which represent 24-week data comparing optimised background therapy, with or without the drug, in more than 1,000 highly treatment-experienced patients with CCR5-tropic HIV-1. The company also noted that its previously announced multinational expanded-access programme to provide maraviroc to patients with limited available treatment options is now open for enrolment.
If maraviroc does gain approval, competition could come from Schering-Plough’s vicriviroc, which is currently in Phase II.
CAROLINE: PIC = MEDICAL 00012752