Telaprevir (VX-950) is an investigational oral protease inhibitor (PI) for the treatment of hepatitis C virus (HCV) infection. HCV protease is a unique HCV enzyme that plays a key role in viral replication and may also help the virus evade host immune defenses.
To date, more than 2,500 people with hepatitis C have received telaprevir-based regimens as part of Phase 2 studies and the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together, these studies enrolled people with genotype 1 hepatitis C who had not been treated for their disease previously as well as people who had been treated before but did not achieve a sustained viral response, or viral cure. The telaprevir clinical development program is the largest conducted to date for any investigational direct-acting antiviral hepatitis C therapy. Vertex plans to submit a New Drug Application to the U.S. Food and Drug Administration in the fourth quarter of 2010.
Telaprevir is being developed by Vertex Pharmaceuticals in collaboration with Tibotec Pharmaceuticals and Mitsubishi Tanabe Pharma. Vertex retains commercial rights to telaprevir in North America. Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.
For more information on hepatitis C see our hepatitis c backgrounder.