Janssen Submits sNDA To FDA For Olysio With Sofosbuvir In Genotype 1 Chronic Hepatitis C
By Cyndi Root
Janssen Research & Development announced in a press release that it has submitted a Supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Olysio (simeprevir). The NS3/4A protease inhibitor is to be used in combination with Gilead Sciences’ sofosbuvir. The drug combination 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. Olysio is already approved for treatment of chronic hepatitis C infection.
Gaston Picchio, Hepatitis Disease Area Leader at Janssen Research & Development said, “Hepatitis C places a significant burden on the lives of those infected and if left untreated may cause significant damage to the liver, including cirrhosis and complications such as liver failure.”
Olysio
Olysio (simeprevir) is a protease inhibitor that blocks the HCV NS3/4A protease, which is needed by the hepatitis C virus to replicate. In the approved indication, it is used in combination with antiviral agents peginterferon-alfa and ribavirin. Hepatitis C adult patients who have never been treated or who have not responded to other treatments are the best candidates for Olysio in the approved indication. In the supplemental filing, Olysio is intended for use with the nucleotide analog NS5B polymerase inhibitor Sovaldi (sofosbuvir).
Olysio Clinical Trials
For the new indication in genotype 1 chronic hepatitis C (HCV), Janssen supported the sNDA with results from the Phase 2 COSMOS study. The 12 week trial of oral simeprevir plus sofosbuvir showed a sustained virological response in 93 percent of genotype 1 patients with mild-to-moderate liver fibrosis. The treatment worked as well as other treatments, including ribavirin. Janssen recently began a Phase III trial, the OPTIMIST trials, which will study simeprevir and sofosbuvir without interferon or ribavirin.
Olysio Marketing
Janssen developed Olysio and retains worldwide marketing rights, with a few exceptions. Medivir AB holds marketing rights in Nordic countries, authorized by Janssen-Cilag International NV. Janssen-Cilag filed a Marketing Authorization Application to the European Medicines Agency (EMA) in April of 2013 for Olysio.
Genotype 1 Chronic Hepatitis C
Approximately three quarters of Americans who have HCV, have genotype 1 chronic hepatitis C. The genotype does not play a significant role in the progression of the disease, but rather in the treatment of the virus. Genotype 1 has proven more difficult to treat than types 2 or 3.