Janssen's Olysio/sofosbuvir combination cleared by FDA

6 November 2014

The Food and Drug Administration has approved US health care giant Johnson & Johnson's (NYSE: JNJ) Olysio (simeprevir) in combination with sofosbuvir (Gilead Sciences’ new blockbuster hepatitis C drug Sovaldi) as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C infection in adult patients as part of a combination antiviral treatment regimen.

The supplemental New Drug Application was filed in May by J&J subsidiary Janssen Research & Development, which developed Olysio – which is already approved and marketed for hepatitis C - with Swedish drugmaker Medivir (OMX: MVIR).

Supporting data for the approval

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