The US Food Administration has approved Merck’s Victrelis (boceprevir), the first treatment for hepatitis C to be endorsed in almost a decade.
Victrelis has been approved for the treatment of CHC genotype 1 infection in combination with antiviral drug ribavirin and peginterferon, an immune-boosting protein sold by Merck as PegIntron and Basel, and by Roche as Pegasys.
Advisors to the US Food and Drug Administration voted unanimously to support Merck’s drug, which beat Vertex Pharmaceuticals’ hepatitis C treatment telaprevir in its race for clearance.
Bruce Bacon, professor of internal medicine at Saint Louis University School of Medicine in Missouri, US, and a clinical investigator for Victrelis, said that the drug can significantly increase a patient’s chance of achieving undetectable levels of the virus.
Merck president and CEO Kenneth Frazier said, “Merck is deeply committed to innovation in bringing forward new medicines that significantly address unmet medical needs, and Victrelis is a shining example of our commitment being realized.”
Victrelis is a direct-acting antiviral agent that interferes with the ability of the hepatitis C virus to replicate itself by inhibiting a viral enzyme.
The current standard therapy for hepatitis C works to strengthen the body’s natural immune response to the virus, but only about 40% of patients with chronic hepatitis C genotype 1 infection are able to achieve a sustained virologic response.
Two large Phase III clinical studies found that the addition of Victrelis to ribavirin and peginterferon in patients who have failed previous treatment resulted in nearly a three-fold increase in sustained virologic response rates.