The European Commission (EC) has cleared for marketing the protease inhibitor simeprevir (Olysio, Janssen/Medivir AB) for treatment of adults with hepatitis C (HCV) genotypes 1 and 4 infection in combination with other drugs, the companies announced May 16.
Simeprevir "provides a new triple therapy treatment option, as well as the first ever 12-week interferon-free and ribavirin independent treatment regimen, in combination with sofosbuvir, for appropriate patients in Europe," according to a Medivir news release.
The EC approval for simeprevir with pegylated interferon (PegIFN) plus ribavirin (RBV) is based on 3 pivotal phase 3 studies involving more than 1000 patients. The trials, TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-Naive, Genotype 1 Hepatitis C-Infected Patients (QUEST-1), TMC435-TiDP16-C216 - Phase III Trial of TMC435 in Treatment-Naive, Genotype 1 Hepatitis C-Infected Patients (QUEST-2), and An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-Infected Patients Who Relapsed After Previous Therapy (PROMISE), tested simeprevir in combination with PegIFN and RBV in treatment-naive patients and patients who have relapsed after prior IFN-based treatment.
All 3 studies met their primary endpoints and demonstrated that simeprevir in combination with PegIFN/RBV achieves significant cure rates when compared with PegIFN/RBV alone, the company said.
The EC approval for the combination of simeprevir and sofosbuvir also contains the phase 2 Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders to Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients (COSMOS) study, which included prior null responder and treatment-naive patients.
Simeprevir is taken once daily for 12 weeks, with treatment-naive and prior-relapser patients receiving PegIFN/RBV for 24 weeks, or for 48 weeks total by those shown to be prior nonresponder patients (including partial and null responders).
The most common adverse events reported in clinical trials of simeprevir (incidence, ≥5%) include nausea, rash, pruritus, dyspnea, blood bilirubin increase, and photosensitivity reaction.
A Janssen news release states that the drug is expected to become available in the European Union in the second half of 2014.
The EC approval follows a positive opinion on simeprevir in March by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Simeprevir was approved by the US Food and Drug Administration in November 2013.
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Cite this: Hepatitis C Drug Simeprevir (Olysio) Cleared in EU - Medscape - May 19, 2014.