Supplemental New Drug Application Submitted to FDA by Janssen
July 22, 2014
ISSUE: JULY 2014
Janssen Submits Supplemental NDA For Olysio for Once-Daily Use In Combination With Sofosbuvir
On May 7, Janssen announced the submission of a Supplemental New Drug Application (sNDA) to the FDA for simeprevir (Olysio), an NS3/4A hepatitis C virus (HCV) protease inhibitor, in combination with the NS5B HCV polymerase inhibitor, sofosbuvir (Sovaldi, Gilead Sciences). Janssen is seeking regulatory approval of the combination for the treatment of HCV genotype 1 infection in treatment-naive patients with advanced liver fibrosis and in null responders with all stages of liver fibrosis.
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