Janssen Submits Supplemental New Drug Application to FDA for Olysio (simeprevir)

Janssen said on May 7 that it had submitted a Supplemental New Drug Application (sNDA) for Olysio (simeprevir), an NS3/4A protease inhibitor. The drug will be used in combination with the nucleotide analog NS5B polymerase inhibitor sofosbuvir, developed by Gilead Sciences.

This 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, Janssen said. Currently approved for the treatment of chronic hepatitis C infection as part of a combo antiviral treatment regimen, Olysio’s efficacy is established when used with peginterferon alfa and ribavirin in HCV genotype 1-infected patients with liver disease.

The regulatory submission was supported by data from the Phase 2 COSMOS study which included treatment-naive patients with advanced fibrosis and null-responder patients with all stages of liver fibrosis.

"This filing brings us closer to potentially offering these patients a once-daily, all-oral treatment combination that includes the direct-acting antiviral agents simeprevir and sofosbuvir," said Gaston Picchio, Janssen’s hepatitis disease area leader.

Janssen announced in April the start of the Phase 3 OPTIMIST trials, which will examine the safety and efficacy of simeprevir and sofosbuvir for the treatment of chronic genotype-1 HCV infection, without the use of interferon or ribavirin. — Kellen Owings

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