US FDA grants priority review for Janssen's simeprevir, accepts Biogen Idec's Eloctate and Actavis' progestin-only patch filing
The US Food and Drug Administration has granted Priority Review to the New Drug Application for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease under development at Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development.
"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, at Janssen Research & Development, adding: "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."
Hep C market set to grow to $21 billion in 2018
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