The Antiviral Drugs Advisory Committee of the US Food and Drug Administration (FDA) has unanimously (19-0) recommended approval of Medivir’s simeprevir (TMC435) for combination treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis.
If approved, the once-daily administered Simeprevir 150mg capsules will be given to patients in combination with interferon and ribavirin for the most common form of hepatitis C.
The FDA committee recommended the approval based on data secured from clinical trials of simeprevir in patients who are treatment-naïve or who have failed previous interferon-based therapy.
Medivir CEO Maris Hartmanis said: "The recommendation from the advisory committee is indeed a very positive event for Medivir and we hope that it will lead to a rapid approval of simeprevir by the FDA."
Johnson & Johnson’s unit Janssen R&D Ireland and Medivir are jointly developing the investigational NS3/4A protease inhibitor ‘simeprevir’ for the treatment of genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis
Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells; it is under development for the treatment of chronic hepatitis C in the US and Europe.
Clinical development of simeprevir is overseen by Janssen R&D Ireland and its affiliated companies, which also have exclusive, worldwide marketing rights, except for the Nordic countries where Medivir have retained the marketing rights.
In September 2013, Simeprevir received approval in Japan for the treatment of genotype 1 hepatitis C, while in April Janssen-Cilag International submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of the drug for the treatment of genotype 1 or genotype 4 chronic hepatitis C.
According to Medivir, more than 3,700 patients have been treated to date with simeprevir in clinical trials.
Image: High magnification micrograph of a liver with cirrhosis. Photo: courtesy of Nephron.