FDA GRANTS FAST-TRACK STATUS FOR VIROPHARMA'S MARIBAVIR

ViroPharma has announced that the FDA has granted fast-track designation for maribavir, an oral antiviral drug candidate for the prevention of cytomegalovirus (CMV) infection in allogeneic bone marrow (stem cell) and solid organ transplant patients.

Maribavir is a potent and selective, orally bioavailable antiviral drug with a unique mechanism of action against cytomegalovirus and a favorable early clinical safety profile. It is a potent member of a new class of drugs called benzimidazole ribosides. Unlike currently available anti-CMV agents that inhibit CMV DNA polymerase, maribavir inhibits viral DNA assembly and inhibits egress of viral capsids from the nucleus of infected cells. Maribavir is active in vitro against strains of CMV that are resistant to commonly used anti-CMV drugs.