Simeprevir is an inhibitor of the HCV NS3/4A protease that has beenjointly developed by Janssen R&D Ireland and Medivir AB. Simeprevir (OLYSIO®) was approved in the USA in 2013 and granted marketing authorisation in the EU in May 2014. Additional marketing authorisations were subsequently granted in many other countries around the world. Simeprevir is approved as part of an antiviral combination treatment regimen for chronic genotype 1 and 4 hepatitis C infection in adult patients with compensated liver disease, including cirrhosis (the indications vary between different markets). Janssen is responsible for the global clinical development of simeprevir and owns the exclusive global marketing rights to the drug with the exception of the Nordic region, where Medivir has retained the marketing rights.
HCV NS3/4A protease inhibitors (PIs) block the enzyme activity leading, in turn, to arrest of virus replication in the host cell. Simeprevir is a second generation protease inhibitor with a high degree of potency, medium to high barrier to resistance, minor side effects, and better pharmacokinetics (including a once daily dosage) compared to first-generation PIs.
Janssen R&D Ireland (Johnson & Johnson)
Project status and Medivir participation
Simeprevir is approved for marketing in many countries around the world. Medivir receives royalties on sales of simeprevir.