Simeprevir approved in the US
Note: The marketing authorisation for simeprevir has since been withdrawn by Janssen (on 1 May 2018) so this drug is no longer available in the EU.
FDA news release
On 22 November 2013, the US FDA approved simeprevir 150 mg capsules for the treatment of chronic hepatitis C (CHC) infection.
Approval is based on use as a component of a combination antiviral treatment regimen with peginterferon alfa and ribavirin.
Simeprevir is a hepatitis C virus (HCV) NS3/4A protease inhibitor.
- Simeprevir must not be used as monotherapy.
- Simeprevir efficacy in combination with peginterferon alfa and ribavirin is influenced by baseline host and viral factors.
- Simeprevir efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism at baseline compared to patients infected with hepatitis C virus (HCV) genotype 1a without the Q80K polymorphism. Screening patients with HCV genotype 1a infection for the presence of virus with the NS3 Q80K polymorphism at baseline is strongly recommended. Alternative therapy should be considered for patients infected with HCV genotype 1a containing the Q80K polymorphism.
Simeprevir is manufactured by Janssen Pharmaceuticals and is marketed under the trade name Olysio.
For full details, see the US Summary of Product Characteristics. 
- FDA press release. Olysio (simeprevir) for the treatment of chronic hepatitis C in combination antiviral treatment. (22 November 2013). (Includes Reduced version of the simeprevir SPC).
- Simeprevir Summary of Product Characteristics (US).