The US FDA's Antiviral Drugs Advisory Committee has recommended approval for Medivir's investigational protease inhibitor simeprevir (TMC435) 150mg capsules for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis.
Following approval, 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 committee had recommended the approval, based on data from clinical trials of simeprevir in patients who are treatment-naive 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."
Janssen R&D Ireland and Medivir are jointly developing the 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.
Medivir said simeprevir works by blocking the protease enzyme that allows the hepatitis C virus to replicate in host cells.
Janssen R&D Ireland and its affiliated companies are overseeing the clinical development of simeprevir, while they also have exclusive, worldwide marketing rights, except for the Nordic countries where Medivir have retained the marketing rights.
Simeprevir got approval in Japan for the treatment of genotype 1 hepatitis C in September 2013, while in April Janssen-Cilag International filed a marketing authorization application to the European Medicines Agency (EMA) seeking approval for the treatment of genotype 1 or genotype 4 chronic hepatitis C.