FDA Puts HCV Drug on Fast Track

ViroPharma, Inc.’s HCV-796 for hepatitis C virus infection has been granted fast track designation by the FDA. HCV-796, an orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently in Phase II trials and is being co-developed with Wyeth Pharmaceuticals.

“The receipt of fast track designation for HCV-796 is an important regulatory step forward as we continue to work closely with the FDA and our Wyeth colleagues throughout the development process,” commented Robert Pietrusko, Pharm.D., ViroPharma’s vice president of global regulatory affairs and quality.

Fast track designation may potentially expedite the review of a drug that demonstrates the potential to address an unmet medical need for a serious life-threatening condition. It allows the FDA to accept, on a rolling basis, portions of a marketing application for review prior to the completion of the final registration package.