— Filing Based on Phase 3 Data in Treatment-Naïve and Treatment-Experienced Patients with Compensated Liver Disease —
RARITAN, N.J., March 28, 2013
/PRNewswire/ — Janssen Research & Development, LLC (Janssen) 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.
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 3.2 million people in the United States. When left untreated over time, HCV can cause significant damage to the liver, including cirrhosis.
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
(TMC435) is an investigational NS3/4A protease inhibitor jointly
developed by Janssen and Medivir AB for the treatment of genotype 1
chronic hepatitis C in adult patients with compensated liver disease.
Simeprevir is believed to work by blocking the protease enzyme that
enables the hepatitis C virus to survive and replicate in host cells.
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