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news.Vertex Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for its INCIVEK (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.
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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.