ViroPharma granted fast track status by FDA for new hepatitis C virus infection treatment

Transplant News, July, 2007

ViroPharma, Inc., Exton, PA, announced the FDA has granted fast track designation for HCV-796 for the treatment of hepatitis C virus infection (HCV). The company says VCV-796 is a unique orally dosed non-nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of HCV. The drug is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth, Collegeville, PA.

Under the FDA Modernization Act of 1997, fast track designation may potentially expedite the review 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. Fast track designation 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. The designation does not guarantee approval or expedited approval of any application for the product.

Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection.

Contact: William Roberts - Phone: (610) 321-6288; Web site: www.viropharma.com