Janssen submits HCV combo to FDA

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J&J's Janssen submitted a supplemental new drug application for HCV treatment Olysio (simeprevir) combined with sofosbuvir today for the treatment of genotype 1 patients with liver scarring (fibrosis).

Simeprevir was approved in November 2013 for patients with chronic HCV in combination with peginterferon and ribavirin. The drug was co-developed by Medivir AB.

MM&M reported in November that Janssen was “committed to patient education” for the drug, and would also offer diagnostic testing to providers in a bid to improve access.

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