Janssen Research & Development has submitted a supplemental new drug application (sNDA) to US Food and Drug Administration (FDA) for Olysio (simeprevir) for once-daily use in combination with sofosbuvir for 12 weeks for the treatment of adult patients with genotype 1 chronic hepatitis C.
Simeprevir is a NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, while sofosbuvir is a NS5B polymerase inhibitor developed by Gilead Sciences.
Janssen has filed the sNDA with the FDA for Olysio and sofosbuvir for the treatment of genotype 1 chronic hepatitis C (HCV) in adult treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis.
Olysio is approved to treat chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Efficacy of Olysio was established in combination with peginterferon alfa and ribavirin in HCV genotype 1-infected patients with compensated liver disease, including cirrhosis.
Janssen research and development hepatitis disease area leader Gaston Picchio said: "This filing brings us closer to potentially offering these patients a once-daily all-oral treatment combination that includes the direct-acting antiviral agents simeprevir and sofosbuvir."
Submission of the sNDA for Olysio and sofosbuvir is based on positive data from the Phase II COSMOS study, which included treatment-naive patients with advanced fibrosis (METAVIR F3 to F4 scores) and null-responder patients with all stages of liver fibrosis (METAVIR F0 to F4 scores).
Janssen initiated the Phase III OPTIMIST trials, which are designed to evaluate the safety and efficacy of simeprevir and sofosbuvir without interferon or ribavirin for the treatment of chronic genotype 1 HCV infection.
In the first trial, known as OPTIMIST-1, the combination of simeprevir and sofosbuvir will be given once-daily for eight or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment naive or treatment experienced.
In the second trial, known as OPTIMIST-2, the combination will be given once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment naive or treatment experienced.
Janssen was responsible for the global clinical development of simeprevir. The company has worldwide marketing rights for simeprevir, except in the Nordic countries, while Medivir retains marketing rights for simeprevir in these countries under the marketing approval held by Janssen-Cilag International.
Simeprevir received Japanese approval in September 2013, with Canadian and US approval in November 2013, and Russian approval in March 2014.
In April 2013, Janssen-Cilag International filed a marketing authorisation application to the European Medicines Agency (EMA) for simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation in the EU for the use of simeprevir in combination with other medicinal products for the treatment of chronic HCV. Currently, this application is under review by the EMA.
Image: Electron micrograph of hepatitis C virus. Photo: courtesy of TimVickers.