Janssen Research & Development, LLC recently announced that its investigational hepatitis C treatment has been granted Priority Review by the US Food and Drug Administration (FDA).
Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once-daily with pegylated interferon and ribavirin for genotype 1 chronic hepatitis C adult patients with compensated liver disease. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
Hepatitis C virus (HCV) is an infectious disease of the liver. It affects about 3.2 million people in the United States and 150 million worldwide. HCV can cause serious damage to the liver, including cirrhosis, when left untreated over time. Cirrhosis can cause serious complications, including liver failure. Approximately 350,000 people die from hepatitis C per year.
“Hepatitis C is a complex disease and Janssen is committed to working with the HCV community, caregivers and healthcare systems to address this global epidemic,” Gaston Picchio, Hepatitis Disease Area Leader, Janssen Research & Development stated. “We are pleased that the FDA has granted simeprevir Priority Review, as it is a significant step forward in making this therapy available to physicians and their hepatitis C patients.”
Submission for the investigational drug is based in part by data from three pivotal Phase III studies, including QUEST-1, QUEST-2, and PROMISE. QUEST-1 and QUEST-2 evaluated simeprevir in treatment-naïve patients and PROMISE evaluated the drug in patients who have relapsed after prior interferon-based treatment.
Additionally, the company has submitted simeprevir for marketing authorization to regulatory authorities in Europe and Japan.
Source: Janssen Research & Development
Last Updated: 5/14/13; 9:35AM EST