Vertex Pharmaceuticals Incorporated has been granted fast track designation for VX-950, an investigational oral hepatitis C virus (HCV) protease inhibitor for the treatment of HCV infection by the US FDA.

Chronic hepatitis C virus infection is a serious and life-threatening disease. VX-950 has the potential to shorten the duration of therapy compared to the standard of care, which may result in improved sustained virologic response rates and a more favourable adverse event profile. Vertex is currently conducting a clinical development programme to assess whether VX-950 will address these unmet medical needs in HCV therapy, maintains a company release.

Under the FDA Modernisation Act of 1997, fast track designation indicates that the FDA will facilitate the development and may expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need for such a condition.

Earlier in 2005, Vertex concluded a 14-day, phase Ib study of VX-950 that showed a rapid and dramatic reduction in HCV RNA in HCV patients when VX-950 was administered as a single agent.

Hepatitis C is a liver disease caused by the hepatitis C virus, which is found in the blood of people with the disease. HCV, a serious public health concern affecting 3.4 million individuals in the United States, is spread through direct contact with the blood of infected people.

Vertex Pharmaceuticals Incorporated is a global biotechnology company that discovers and develops small molecule drugs for serious diseases.