Regulatory updates for Incivek, Xgeva and Corlux in North America

In a batch of regulatory news released yesterday, Vertex Pharmaceuticals (Nasdaq: VRTX) said that Health Canada has approved Incivek (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver).

Incivek, which received US approval earlier this year and gained a positive recommendation for clearance in Europe (The Pharma Letters May 24 and July 23), is approved in Canada for use in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C, and is indicated for people who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure). Incivek is approved for use in all three major groups of people who did not achieve a viral cure despite prior treatment including: relapsers, partial responders and null responders.

PDUFA action date for Amgen’s Xgeva sBLA