Janssen applies for Olysio label expansion

|By:, SA News Editor

Johnson & Johnson's (JNJ +1%) Janssen Pharmaceuticals unit submits an sNDA to the FDA for the use of Olysio (simeprevir) with Gilead Sciences' (GILD -0.2%) NS5B polymerase inhibitor sofosbuvir for the treatment of genotype 1 chronic hepatitis C in adult treatment-naive patients with advanced fibrosis and null responders with all stages of fibrotic disease. The product is currently approved as a combination therapy with peginterferon alfa and ribavirin as a treatment for HCV-1 for compensated liver disease including cirrhosis.

The company's regulatory submission is based on data from the Phase 2 Optimist trial which included the fibrosis and null-responding patients cited above.

Last month, Janssen started a Phase 3 trial to examine the safety and efficacy of simeprevir and sofosbuvir without interferon or ribavirin for the treatment of HCV-1 patients.