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Janssen’s HCV Therapy Receives FDA Priority Review

The US Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor  manufactured by Raritan, NJ-based Janssen Research & Development. Protease inhibitors work by blocking the enzyme protease, preventing the hepatitis C virus (HCV) from replicating inside host cells.


Simeprevir is administered as a daily oral capsule in combination with pegylated interferon and ribavirin. It is designed for the treatment of adult patients with genotype 1 chronic HCV infection with compensated liver disease (advanced liver disease that is stabilized), including all stages of fibrosis. Individuals with genotype 1, an especially difficult-to-treat type of the virus, account for approximately 70% of HCV patients.


The FDA grants Priority Review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. The regulatory submission for simeprevir is supported in part by data from three Phase 3 studies: QUEST-1 and QUEST-2 in previously  untreated patients, and PROMISE in patients who had relapsed after prior interferon-based treatment.


“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,” said Gaston Picchio, Hepatitis Disease Area Leader, Janssen Research & Development. “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.”


Janssen also recently submitted simeprevir for marketing authorization to regulatory authorities in Japan and Europe. The FDA review is expected to be completed by the end of November.


Janssen, which specializes in neuroscience, oncology, immunology, infectious diseases and vaccines, and cardiovascular and metabolism, has affiliated facilities in Europe, the US and Asia.


Source:, May 13, 2013