You are here
Supplemental New Drug Application Submitted to FDA for Simeprevir/Sofosbuvir Combo
A supplemental new drug application (sNDA) has been submitted to the FDA for simeprevir, an NS3/4A protease inhibitor marketed as Olysio (Medivir/Janssen) in the U.S., in combination with the nucleotide analogue NS5B polymerase inhibitor sofosbuvir, developed by Gilead Sciences, Inc.
Olysio (simeprevir) is currently approved in the U.S. for the treatment of chronic hepatitis C virus (HCV) infection as a component of a combination antiviral treatment regimen. The efficacy of simeprevir has been established in combination with peginterferon (peg-IFN) alfa and ribavirin in patients infected with genotype-1 HCV with compensated liver disease, including cirrhosis.
The new regulatory submission is for the treatment of genotype-1 chronic HCV infection in adult treatment-naïve patients with advanced fibrosis and in null responders with all stages of liver fibrosis.
The regulatory submission for the combination of simeprevir and sofosbuvir was supported by data from the phase II COSMOS trial, which included treatment-naïve patients with advanced fibrosis and prior null-responder patients with all stages of liver fibrosis.
In April 2014, two phase III trials were initiated to evaluate the safety and efficacy of simeprevir and sofosbuvir without IFN or ribavirin for the treatment of chronic genotype-1 HCV infection. In the first trial, known as OPTIMIST-1, the combination will be administered once daily for 8 or 12 weeks in patients infected with chronic genotype-1 HCV without cirrhosis who are HCV treatment-naive or treatment-experienced. In the second trial, known as OPTIMIST-2, the combination will be administered once daily for 12 weeks in patients infected with genotype-1 HCV with cirrhosis who are HCV treatment-naive or treatment-experienced.
Simeprevir is an NS3/4A protease inhibitor indicated for the treatment chronic HCV infection in combination with peg-IFN and ribavirin in patients infected with genotype-1 and genotype-4 HCV with compensated liver disease, including cirrhosis.
Source: Medivir; May 7, 2014.