Pharmaceutical Business review

Vertex Pharma hepatitis C drug receives FDA approval

INCIVEK is an oral medicine that acts directly on the hepatitis C virus protease, an enzyme essential for viral replication.

The approval of INCIVEK was based on data from three Phase 3 studies, which show that people who received INCIVEK combination treatment achieved higher rates of sustained viral response (SVR, or viral cure) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience.

With INCIVEK combination treatment, more than 60% of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks – half the time needed if they were to take pegylated-interferon and ribavirin alone.

Vertex developed telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma.