The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for simeprevir (Olysio 150 mg, Janssen-Cilag International NV) for the treatment of adults with hepatitis C in combination with other products.
"The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Olysio and therefore recommends the granting of the marketing authorization," the committee said in a statement.
In the United States, the once-daily protease inhibitor was approved by the US Food and Drug Administration in November 2013, based on clinical trials in which both treatment-naive and treatment-experienced patients with chronic hepatitis C genotype 1 received the drug in combination with 2 antivirals, ribavirin and peginterferon-alfa.
Sustained virologic responses at 12 weeks were 80% for treatment-naive patients and 79% for those who had previously relapsed on other agents, as reported by Medscape Medical News.
Common adverse effects of simeprevir (in 5% or more of patients) include nausea, rash, pruritus, dyspnea, blood bilirubin increase, and photosensitivity reaction. A pharmacovigilance plan for simeprevir will be implemented as part of the marketing authorization.
The CHMP advises that simeprevir be prescribed by physicians experienced in the treatment of chronic hepatitis C. Detailed recommendations for product use will be made available to prescribers in all official European Union languages.
In a related opinion, the CHMP also advised expanding the indication for peginterferon-alfa (Pegasys, Roche Registration Ltd) to include use with "other medicinal products" for the treatment of chronic hepatitis C in adults with compensated liver disease; for pediatric patients aged 5 years and older, the indication would remain "in combination with ribavirin."
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Cite this: CHMP Endorses Hepatitis C Treatment Simeprevir - Medscape - Mar 21, 2014.