EC Gives Marketing Authorization to Hepatitis Drug Olysio

The European Commission has given marketing authorization to Olysio (simeprevir) for the treatment of adults with hepatitis C (HCV) genotype 1 and 4 infection, its drugmaker Janssen-Cilag said.

Depending on the patient’s condition, Olysio provides a triple treatment option, to be used as part of a combination therapy with sofosbuvir or pegylated interferon (PegIFN) and with or without ribavirin (RBV), the company said.

Conditions and necessary combinations are as follows:

• Patients with HCV genotype 1 or 4, who are intolerant or ineligible for interferon treatment and regardless of prior treatment, should take simpervir and sofosbuvir, with or without RBV for 12 weeks.
• Treatment-naïve and prior relapse patients with genotype 1 or 4, with or without cirrhosis and those co-infected with HIV should take simeprevir, PegIFN and RBV together for 24 weeks.
• Prior non-responder patients (including partial and null responders) with genotype 1 or 4 and those co-infected with HIV should take simeprevir, PegIFN and RBV together for 48 weeks.

The company said Japan approved simeprevir for the treatment of genotype 1 HCV in March 2013. It was approved for the same treatment by the Canada and the U.S. in September and November, 2013, respectively. — Kellen Owings

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