Janssen Research & Development, LLC today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients.
"Hepatitis C is a complicated disease and genotype 1 hepatitis C can be particularly 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," said Wim Parys, Global Head of Development, Infectious Diseases and Vaccines, Janssen. "The U.S. filing represents an important step forward in bringing simeprevir to market and in helping to battle this challenging disease." Hepatitis C virus (HCV) is a blood-borne infectious disease of the liver that affects approximately 3.
million people in the United States. When left untreated over time, HCV can cause significant damage to the liver, including cirrhosis.
The regulatory submission for simeprevir is supported in part by data from three pivotal Phase 3 studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. In each study, participants were treated with one 150 mg simeprevir capsule once daily for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks.
Primary efficacy data from the Phase 3 studies will be presented at an upcoming medical meeting.