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news.The FDA has granted fast track designation for ViroPharma's oral antiviral drug candidate, maribavir, for the prevention of cytomegalovirus infection in bone marrow and solid organ transplant patients.
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According to the company, infection with CMV, a member of the herpes virus group, averages between 50% and 85% of adults in the US by 40 years of age. In healthy adults the disease causes little to no apparent illness, however in individuals with compromised immune systems, such as those undergoing transplants, the disease can lead to serious disease or death.
ViroPharma completed enrollment in a phase II study of maribavir in recipients of bone marrow (stem cell) transplant in November 2005, and expects to release the preliminary data from the trial by the end of the first quarter of 2006.
“There is an unmet medical need for improved treatments for the prevention of cytomegalovirus infection and disease in transplant patients due to the limitations of current therapies, which include potential bone marrow and renal toxicities,” commented Dr Colin Broom, ViroPharma’s chief scientific officer.
Fast track designation may potentially expedite the review and accelerate approval of a drug that is intended for the treatment of a serious life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.