Janssen’s hepatitis C drug Olysio cleared in EU
Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), says that its next generation protease inhibitor (PI) Olysio (simeprevir) has been granted marketing authorisation by the European Commission for the treatment of adults with genotype 1 and 4chronic hepatitis C (CHC), in combination with other medicinal products, which includes:]
Patient population | Treatment | Duration |
Patients with HCV genotype 1 or 4, regardless of prior treatment history and who are intolerant to or ineligible for interferon (IFN) treatment | Simeprevir + sofosbuvir, with or without ribavirin (RBV) | 12 weeks |
Treatment-naive and prior relapse patients with genotype 1 or 4 with or without cirrhosis and those co-infected with human immunodeficiency virus (HIV) | Simeprevir + pegylated interferon (PegIFN) + RBV | 24 weeks Treatment with simeprevir must be initiated in combination with PegIFN + RBV and administered for 12 weeks, followed by an additional 12 weeks ofPegIFN + RBV |
Prior non-responder patients (including partial and null responders) with HCV genotype 1 or 4 and those co-infected with HIV | Simeprevir + PegIFN + RBV | 48 weeks Treatment with simeprevir must be initiated in combination with PegIFN + RBV and administered for 12 weeks, followed by an additional 36 weeks ofPegIFN + RBV |
This marketing authorization 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 IFN-free direct-acting antiviral (DAA) regimen with or without RBV, in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment, the company noted.
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