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US approval of Simeprevir

Medivir has received US approval of its Simeprevir for the treatmeant of hepatitis C.

On Friday 22 Medivir and Janssen’s drug candidate Simeprevir was approved for the US market by the Food and Drug Administration (FDA). The product will be approved for the 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. The USA approval triggers a milestone payment of EUR 10 million to Medivir.

“The USA approval is a large and important milestone in the global strategy that our partner Janssen has for simeprevir, to offer a new treatment option to many different hepatitis C patient groups” said Maris Hartmanis CEO, Medivir.

Earlier this month the company announced the approval of Simeprevir on the Canadian market.