Janssen Research & Development is seeking US FDA approval for the use of Simeprevir (TMC435) in combination with pegylated interferon and ribavirin to treat genotype 1 chronic hepatitis C in adults.
The company submitted a new drug application to FDA based on Phase 3 data in treatment-na?ve and treatment-experienced patients with compensated liver disease.
Application is filed for administration of the investigational NS3/4A protease inhibitor simeprevir, as a 150mg capsule on daily basis with pegylated interferon and ribavirin against genotype 1 chronic hepatitis C.
Janssen development, infectious diseases and vaccines global head Wim Parys said Hepatitis C is a complicated disease and especially genotype 1 hepatitis C can be difficult to cure.
"Given the complexity and diversity of the patient population, physicians need multiple options to provide their patients a chance at treatment success," Parys added.
"The U.S. filing represents an important step forward in bringing simeprevir to market and in helping to battle this challenging disease."
