Janssen R&D announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for simeprevir, an NS3/4A protease inhibitor in combination with sofosbuvir, a nucleotide analog NS5B polymerase inhibitor for the treatment of genotype 1 chronic hepatitis C virus (HCV) in treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis.
The submission for simeprevir and sofosbuvir is based on data from the Phase 2 COSMOS study which included treatment-naive patients with advanced fibrosis (METAVIR F3 to F4 scores) and null-responder patients with all stages of liver fibrosis (METAVIR F0–F4 scores).
In April 2014, Janssen announced initiation of the Phase 3 OPTIMIST trials examining the safety and efficacy of simeprevir and sofosbuvir without interferon or ribavirin for the treatment of chronic genotype 1 HCV infection. In the first trial (OPTIMIST-1), the combination will be administered once daily for 8 or 12 weeks in chronic HCV genotype 1 infected patients without cirrhosis who are HCV treatment-naive or treatment-experienced. In OPTIMIST-2, the combination will be administered once daily for 12 weeks in HCV genotype 1 infected patients with cirrhosis who are HCV treatment-naive or treatment-experienced.
Olysio (simeprevir; Janssen Therapeutics) is already approved for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients with compensated liver disease, including cirrhosis. Sovaldi (sofosbuvir; Gilead Sciences) is also already approved as a component of a combination antiviral treatment regimen for CHC genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection.
For more information call (800) 457-6399 or visit JanssenRnD.com.