Table of Contents
CAMBRIDGE, Mass. — Vertex Pharmaceuticals Inc. has gained approval from the Food and Drug Administration for Incivek, a treatment for chronic hepatitis C patients.
The company said Monday that Incivek (telaprevir) tablets were approved 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. Also, the drug was approved for people who are new to treatment and for people who were treated previously but didn’t achieve a viral cure.
According to Vertrex, Incivek is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. After the first 12 weeks, all patients stop receiving Incivek and continue treatment with pegylated-interferon and ribavirin alone for another 12 weeks or 36 weeks of treatment.
The company noted that 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. All other patients will receive a total of 48 weeks of treatment.
"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them," explained Ira Jacobson, M.D., chief of the division of gastroenterology and hepatology at Weill Cornell Medical College and principal investigator for a phase 3 study of Incivek. "With Incivek, 79% of people new to treatment achieved a viral cure."
Slated to become available in pharmacies this week, Incivek (750 mg) is given as two 375-mg tablets three times daily. It comes packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.
"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," stated Matthew Emmens, chairman and chief executive officer of Vertex. "The approval of Incivek was only possible thanks to more than 4,000 people who volunteered for our clinical studies; the doctors, nurses and coordinators who managed the studies; and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."
