STOCKHOLM--(BUSINESS WIRE)--Regulatory News:
Medivir AB (OMX: MVIR) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 19 to 0 to recommend approval of the investigational protease inhibitor simeprevir (TMC435) 150 mg capsules administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis. The Advisory Committee recommended the approval of simeprevir based on analyses of data from clinical trials in patients who are treatment-naïve or who have failed previous interferon-based therapy.
”The recommendation from the Advisory Committee is indeed a very positive event for Medivir and we hope that it will lead to a rapid approval of simeprevir by the FDA,” said Maris Hartmanis, Medivir’s CEO.
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, for the treatment of genotype 1 and genotype 4 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.
Janssen R&D Ireland, and its affiliated companies, are responsible for the global clinical development of simeprevir and have acquired exclusive, worldwide marketing rights, except for the Nordic countries where Medivir AB have retained the marketing rights under the marketing authorization held by Janssen-Cilag International NV.
Simeprevir was approved in Japan in September 2013 for the treatment of genotype 1 hepatitis C. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials
For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease, is the focus of a rapidly evolving treatment landscape. Approximately 150 million people are infected with hepatitis C worldwide – including approximately 3.2 million people in the United States – and 350,000 people per year die from the disease globally. When left untreated, hepatitis C can cause significant damage to the liver including cirrhosis. Additionally, hepatitis C may increase the risk of developing complications from cirrhosis, which may include liver failure.
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. 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 for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
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 health and quality of life.
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