The European Commission has granted marketing authorisation to simeprevir for the treatment of adults with genotype 1 and 4 chronic hepatitis C in combination with other medicinal products.
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir.
The drug is indicated for treatment of chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.
Medivir CEO Maris Hartmanis said approval of simeprevir in Europe is a further step in the company’s partner’s global strategy to enable an improved treatment for hepatitis C patients.
"This also means that Medivir will now be able to offer this treatment to patients in the Nordic region, where we have the marketing rights," Hartmanis said.
Treatment with simeprevir must be started in combination with PegIFN + RBV and administered for 12 weeks and then followed by an additional 36 weeks of PegIFN + RBV.
Marketing approval represents a significant milestone in the development of new triple therapy hepatitis C (HCV) treatment options for genotype 1 and 4 patients.
It also includes simeprevir as part of an all oral 12-week interferon-free direct-acting antiviral (DAA) regimen with or without ribavirin (RBV), in these patients, who are intolerant to or ineligible for IFN treatment.
Approval for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three major Phase III trials QUEST-1, QUEST-2 and PROMISE, with more than 1,000 patients.
These trials explored the use of simeprevir in combination with PegIFN/RBV in treatment-naive patients and patients who have relapsed after prior interferon-base treatment.
Primary endpoints were met in all three trials and showed that simeprevir in combination with PegIFN/RBV, achieves significant cure rates when compared with PegIFN/RBV alone.
EC approval for the combination of simeprevir and sofosbuvir also includes the Phase II trial, COSMOS, which was based upon prior null responder and treatment-naive patients.
