Janssen submits sNDA for Olysio in combination with sofosbuvir

8 May 2014

Janssen Research & Development, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for simeprevir, an its NS3/4A protease inhibitor Olysio (simeprevir) in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir developed and now marketed by Gilead Sciences (Nasdaq: GILD) as Sovaldi.

This regulatory submission is for the treatment of genotype 1 chronic hepatitis C (HCV) in adult treatment-naive patients with advanced fibrosis and null responders with all stages of liver fibrosis.

Olysio is currently approved for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. The drug’s efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1-infected patients with compensated liver disease, including cirrhosis.

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