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Supplemental New Drug Application Submitted to FDA by Janssen

July 22, 2014

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Find out about Janssen’s goal for Olysio to be used once-daily in combination with Sovaldi.

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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  • Michele Turner

    I see its paying off for those of us on the trial having done so well. This is pills dor less than 90 days and they cost more than $1,000 a day. So yea us, we just made a ton of money for this drug company.

  • Roy Gibson

    Michele – Did your insurance pay for the drug?

  • MindFury

    Wow, maybe by the time my insurance approves treatment this will be out. I Was set to start Solvaldi, rin, interferon, but doctor ordered another ultrsound. 3 this year so far. Well the Doctor who looked at the ultra said my pancreas needs a cat scan. Which my insurance will not cover. I swear i want to beat someone. I want control of my life again. I;m just about to say Screw you big pharm and go with cannabis oil all together,