22nd Aug 2011, 10:31 am by Brad Lemaire
Drug maker Vertex Pharmaceuticals (NASDAQ:VRTX) said Monday Health Canada has approved Incivek tablets for patients with chronic hepatitis C.
The drug, also known as telaprevir, is approved for use in combination with pegylated-interferon and ribavirin, two standard treatments used for Hep-C. Specifically, the drug can be used in patients with genotype 1 chronic hepatitis C, with compensated liver disease, meaning there is some damage to the liver, but the liver still functions.
About 170 million people worldwide are chronically infected with Hep-C, including some 250,000 Canadians. the serious liver disease can lead to liver damage, scarring, failure, or liver cancer.
The approval was based on three phase 3 studies of the drug of mroe than 2,500 people with hepatitis C. the results showed that people who took Incivek in combination with the other treatments achieved significantly higher rates of viral cure, compared to those that were treated with standard therapy alone.
The drug is indicated for people that are new to treatment, or did not respond to prior therapy.
“Health Canada’s rapid approval of Incivek underscores the urgent need for new medicines to treat hepatitis C,” said senior vice president and chief medical officer of Vertex, Robert Kauffman.
The company said that until recently, about 40% of people who underwent a year of treatment for Hep-C were cured.
“Incivek’s ability to nearly double that rate of cure and cut treatment time in half for the majority of patients being treated for the first time marks a turning point in the fight against this disease.”
Patients can live with the Hep C virus for many years without detecting any symptoms, leading for calls by some for increased hepatitis testing.
In 2010, the annual cost of hep-C due to medical treatment and lost productivity in Canada was estimated at $1 billion.
Vertex develops and commercializes small molecule drugs for the treatment of diseases. it is engaged in phase-one clinical trials for a host of drug candidates, which include drugs for the treatment for cystic fibrosis and influenza.