Medivir AB announced that Janssen has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Association (FDA) for simeprevir, an NS3/4A protease inhibitor marketed as Olysio in the United States, in combination with the nucleotide analogue NS5B polymerase inhibitor sofosbuvir, developed by Gilead Sciences Inc.
“It is of great importance to continue to improve the treatments for hepatitis C. The supplemental filing of the data available on the combination of simeprevir and sofosbuvir is an important step towards making an efficacious once daily all-oral treatment available for these patients," said Charlotte Edenius, EVP development, Medivir.
Olysio is currently approved in the United States for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Olysio efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1-infected patients with compensated liver disease, including cirrhosis.
This regulatory submission is for the treatment of genotype 1 chronic hepatitis C (HCV) in adult treatment-naïve patients with advanced fibrosis and null responders with all stages of liver fibrosis.
The regulatory submission for Olysio and sofosbuvir is supported by data from the Phase 2 COSMOS study which included treatment-naïve patients with advanced fibrosis (METAVIR F3 to F4 scores) and prior null-responder patients with all stages of liver fibrosis (METAVIR F0 to F4 scores).
Medivir's partner, Janssen R&D Ireland Ltd., initiated in April 2014 the Phase 3 OPTIMIST (Optimal Treatment with a simeprevir and sofosbuvir Therapy) 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, known as 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 the second trial, known as 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.
Date: May 7, 2014