Vertex Pharmaceuticals (NASDAQ:VRTX) treatment for chronic hepatitis C was approved by Health Canada after it showed higher rates of viral cure compared to its rivals, the company said on Monday.
The drug, called Incivek, is targeted for people new to treatment with genotype 1 chronic hepatitis C with compensated liver disease, and for patients that did not achieve a viral cure despite prior treatment.
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Early diagnosis and the effective treatment of hepatitis C are critical to the prevention of long-term consequences of the disease, which may include end-stage cirrhosis, liver cancer and the need for a transplant, said Dr. Eric Yoshida, an INCIVEK investigator.
The drug is an important new treatment option because it has proven to help clear the virus for nearly four out of five patients new to treatment," he said.
The approval of the drug was based on data from three late-stage studies of more than 2,500 people with hepatitis C. It will be used in combination with pegylated-interferon and ribavirin, two other medicines used to treat the disease.
The drug in the Phase III studies achieved significantly higher rates of viral cure compared to those who received pegylated-interferon and ribavirin alone, Vertex said in a statement.
The companys chief medical officer, Dr. Robert Kauffman, said the rapid approval underscores the urgent need for new medicines to treat hepatitis C, which he said affects about a quarter of a million Canadians.