The Potential Role of Simeprevir for the Treatment of Hepatitis C

Cristina del Barrio Gascón; Maria Buti


Future Virology. 2015;10(2):67-75. 

In This Article

Regulatory Affairs

Approval of SMV

The Agency's Committee for Medicinal Products for Human Use has decided that benefits of SMV are greater than the risks and has recommended that the drug be approved for use in the EU. The Committee for Medicinal Products for Human Use concluded that adding SMV to PEG-IFN/RBV considerably increased the number of patients (both previously untreated and treated) showing no signs of infection. The Committee also considered that the data available to date support the use of SMV in combination with sofosbuvir in patients who cannot be given standard treatment including PEG-IFN. Regarding its safety, SMV is considered well tolerated and the side effects, manageable.

The European Commission granted a marketing authorisation valid throughout the EU for SMV on 14 May 2014.