Medivir AB, an emerging research-based pharmaceutical company focused on infectious diseases, has received approval from the Health Canada for simeprevir for treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with ribavirin.

Simeprevir received priority review status and is the first treatment for CHC to be approved for once-daily administration with pegylated interferon and ribavirin in Canada.

In Canada, for a drug to receive priority or accelerated review, it must show effective treatment of a serious, life-threatening or severely debilitating disease or condition for which no drug is presently marketed in Canada. Or, it must show a significant increase in efficacy and/or decrease in risk so that the overall benefit/risk profile is improved over existing therapies for a disease that is not adequately managed by a drug already marketed in Canada.

“Canada is the second market where simeprevir has been approved and will be a new agent in the treatment of hepatitis C. The priority review process shows the importance of offering new treatment options also for the hardest to treat patients and we are very happy that both patients and physicians are given new hope,” said Maris Hartmanis CEO, Medivir.

The approval of simeprevir in Canada is based on four pivotal studies of patients with CHC genotype 1 infection: in treatment-naïve patients (QUEST-1 and QUEST-2), and in patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE (prior non-responders).

Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80 per cent of treatment-naïve patients in the group receiving simeprevir achieved sustained virologic response 12 weeks after the end of treatment (SVR12), compared with 50 per cent of patients in the placebo groups. In PROMISE, 80 per cent of prior-relapser patients in the simeprevir arm of the study achieved SVR12 compared with 37 per cent of patients in the placebo group. Results from ASPIRE demonstrated that use of simeprevir led to sustained virologic response 24 weeks after the end of treatment (SVR24) in 62 per cent of prior partial responder patients and 58 per cent of prior-null responder patients compared with 6 per cent and 15 per cent of prior partial and null-responder patients in the placebo groups, respectively.

Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and its affiliated companies and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the viral protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except for the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these Nordic countries under the marketing authorization held by Janssen-Cilag International NV.

Simeprevir was approved on September 27, 2013 in Japan for the treatment of genotype 1 hepatitis C.