(VRTX) announced that the U.S. Food and Drug Administration (FDA) approved its Incivek (telaprevir) tablets for some patients with genotype 1 chronic hepatitis C with compensated liver disease and/or cirrhosis (liver scarring). Incivek (pronounced in-SEE-veck) was approved for people who are new to treatment and those treated previously without being cured. On May 13, the FDA also approved Victrelis (boceprevir) by Merck (MRK). These two are the first hepatitis C drugs in almost a decade to win FDA approval.
Vertex stated that Incivek should be available in pharmacies now. The company also introduced a comprehensive financial assistance and patient support program to help people who might not otherwise be able to afford the treatment get it and said that more information is available on its Website.
Vertex ran three Phase 3 studies on INCIVEK, indicating people who received it in combination treatment achieved significantly higher rates of sustained viral response (SVR) or cure compared with those who received pegylated-interferon and ribavirin alone, regardless of prior treatment experience. The Phase 3 comparison information from Vertex's release shows a striking improvement in SVR/Cure rates:
Patient Assistance Program