FDA fast tracks ViroPharma's treatment of hepatitis C

ViroPharma has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for HCV-796 for treatment of hepatitis C virus infection.

HCV-796, a unique orally dosed non nucleoside hepatitis C viral polymerase inhibitor that interferes with the replication of hepatitis C virus (HCV), is currently undergoing Phase 2 evaluation and is being co-developed with Wyeth Pharmaceuticals, a division of Wyeth .

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. However, the designation does not guarantee approval or expedited approval of any application for the product.

"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.

Hepatitis C is a blood-borne virus recognized as a major cause of chronic hepatitis worldwide. The World Health Organization estimates that 170 million persons worldwide are infected with HCV, and three to four million persons are newly infected globally each year. According to the U.S. Centers for Disease Control and Prevention (CDC), about four million people in the U.S., or 1.8 percent of the population, are infected with HCV.

Currently, there is no specific antiviral agent directed against HCV that is commercially available, and no vaccine for prevention of HCV infection. Several interferon products are available worldwide, but there are substantial limitations to the use of these products when given as monotherapy or in conjunction with ribavirin in the treatment of chronic HCV infection. In addition to the relatively poor treatment response in patients infected with genotype 1 HCV, the most common strain in the U.S., Western Europe and Japan, the considerable side effects frequently associated with the use of interferon can lead to discontinuation of therapy in approximately 20 percent of patients.

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