FDA panel votes in favour of Janssen’s hepatitis C drug
The US Food and Drug Administration’s Antiviral Drugs Advisory Committee has voted unanimously in favour of recommending Janssen’s hepatitis C drug.
The FDA panel voted 19 to 0 to recommend the approval of the investigational protease inhibitor simeprevir (TMC435) administered once daily as a 150 mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis.
The panel’s decision was based on analyses of data from clinical trials in patients who are treatment naïve or who have failed previous interferon-based therapy.
“We are pleased with the positive recommendation from the Advisory Committee for simeprevir and appreciate the rigorous review of our data. It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C.”
Katia Boven, M.D., Medical Department Head, Infectious Diseases and Vaccines, Janssen.
The FDA granted a Priority Review designation in May to the New Drug Application (NDA) filed by Janssen for simeprevir. The FDA is not bound to follow it’s Committee’s decision, but more often than not, does.
Hepatitis C is a blood-borne infectious disease of the liver and a leading cause of chronic liver disease. 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.
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