U.S. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C
ET | Source:Medivir AB
Stockholm, Sweden — Medivir AB (OMX: MVIR) 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.
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292
Simeprevir is a new generation NS3/4A protease inhibitor jointly developed by
Medivir and Janssen for the treatment of chronic hepatitis C in adult patients
with compensated liver disease.
For additional information about simeprevir clinical trials, please visit
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause
of chronic liver disease and liver transplants, is a rapidly evolving treatment
area with a clear need for innovative treatments. Approximately 150 million
people are infected with hepatitis C worldwide, and about 350,000 people per
year die from the disease.
Medivir is an emerging research-based pharmaceutical company focused on
Medivir has world class expertise in polymerase and protease drug targets and
drug development which has resulted in a strong infectious disease R&D
portfolio. The Company’s key pipeline asset is simeprevir, a novel protease
inhibitor in late phase III clinical development for hepatitis C that is being
developed in collaboration with Janssen R&D Ireland. Medivir has also a broad
product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website:
Medivir is a collaborative and agile pharmaceutical company with an R&D focus on
infectious diseases and a leading position in hepatitis C. We are passionate and
uncompromising in our mission to develop and commercialize innovative
pharmaceuticals that improve people’s lives.
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