Medivir AB (STO:MVIR-B) today announces that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen 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 with compensated liver disease.
"This is a very important step bringing simeprevir closer to the market, making this therapy available to hepatitis C patients" comments Charlotte Edenius, EVP Development of Medivir.
The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins.
The regulatory submission by Janssen for simeprevir is supported in part by data from three pivotal phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in patients who have relapsed after prior interferon-based treatment. Janssen also recently submitted simeprevir for marketing authorization to regulatory authorities in Japan and Europe.