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Medivir's Simeprevir approved for treatment in Russia
Medivir AB (sto:MVIRB.ST), a research-based pharmaceutical company focused on infectious diseases, announced the approval by the Russian Ministry of Health of Sovriad (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.
Reportedly, Russia will be the first country within EMEA to gain access to simeprevir, which represents a significant advance in hepatitis C treatment.
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in adults with compensated liver disease (including cirrhosis) who are treatment naive or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin.
Under the collaboration, Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV.
Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the US. Also, the Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the EU for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.