Summary
Vertex Pharmaceuticals Incorporated (VRTX) announced on August 22, 2011, a significant regulatory milestone: Health Canada has approved INCIVEK™ (telaprevir) tablets. This approval marks a crucial step in expanding access to Vertex's groundbreaking treatment for chronic hepatitis C. The approval is for a broad patient population with genotype 1 chronic hepatitis C and compensated liver disease, including those with cirrhosis. INCIVEK will be used in combination with pegylated-interferon and ribavirin, addressing both treatment-naïve patients and those who have previously undergone treatment without achieving a sustained viral response. This includes key subgroups such as relapsers, partial responders, and null responders, indicating a comprehensive approach to tackling treatment failures in hepatitis C.
Key Highlights
- 1Health Canada has approved INCIVEK™ (telaprevir) tablets.
- 2The approval is for genotype 1 chronic hepatitis C patients with compensated liver disease, including cirrhosis.
- 3INCIVEK™ is approved for use in combination with pegylated-interferon and ribavirin.
- 4The drug is indicated for treatment-naïve patients.
- 5The approval also covers patients who previously received treatment but did not achieve a sustained viral response.
- 6Specifically included are relapsers, partial responders, and null responders, addressing diverse treatment failure scenarios.