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Pioglitazone fda approval : U.S. Food and Drug Administration (FDA) approves new for hepatitis C and related fibrosis liver disease The FDA's approval for combination chemoprophylaxis of hepatitis C (HCV) and fibrosis liver disease (FLLD) in combination with interferon beta-1a provides a new approach for treating and managing HCV FLLD. The new drug, called Nataline, is approved to treat HCV and FLLD in combination with interferon beta-1a, an oral anti hepatitis C drug that is used to treat and prevent the liver disease. Nataline is being developed by Sanofi Pasteur (Nasdaq: SYMC). Nataline blocks the virus from entering red blood cell (RBC) membrane, and therefore prevents the virus from getting in RBC and causing inflammation. Nataline is being prescribed off-label for FLLD and HCV in combination with interferon beta-1a. The is indicated for patients with FLLD who have had a prior positive HCV RNA test (HAMD) or had recently a liver biopsy for HCV. This treatment is approved by the U.S. FDA to treat HCV and FLLD in combination with interferon beta-1a. "Nataline is a novel antiviral agent that can safely and effectively prevent treat liver disease in patients with active fibrosis," said Michael F. Corrigan, M.D., Ph.D., director of the FDA's Center for Drug Evaluation and Research the study's principal investigator at FDA's Center for Drug Evaluation and Research. "Our data from this study will help guide the development of other antiviral agents for the treatment of liver disease. Nataline's combination with interferon beta-1a represents a significant advance in the treatment of these complications and supports our commitment to bring breakthrough therapies patients." The FDA's approval also provides an important advance in reducing costs for patients who are undergoing the interferon beta-1a treatment of HCV and FLLD. The average annual cost of two drugs is estimated to be $50,000 for a single patient, and approximately $250,000 per dose ($120,000 year) for two patients. The approval also provides an estimated savings to the health care system of at least $2.2 billion over the next decade, which FDA estimates will pay for Nataline's development, regulatory oversight, manufacturing, and distribution. "Nataline represents a significant advance in the treatment of HCV and FLLD in combination with interferon beta-1a," said Peter M. Hulak, PhD, executive vice president, Research and Commercialization, Sanofi Pasteur. "We believe that Nataline will be a popular and important treatment for this devastating disease, given the cost-savings and convenience of treatment being provided to patients." Nataline will be available from Sanofi Pasteur in the United States a 3.2-mg oral dose, and in Europe 3.2-mg, 10-mg, 10-mg/mL, and 50-mg, 5-mg, 2.5-mg, 1-mg sublingual formulations. Sanofi Pasteur expects to obtain Nataline regulatory approval in other countries and states as soon possible. About Chronic hepatitis B virus (HBV) Chronic hepatitis B virus (HBV) is a that infects the liver and can be transmitted by sexual contact, blood transfusion, and by contact with an infected mother while she is pregnant. HBV infection can cause chronic liver disease, including cirrhosis, fibrosis, cancer, and liver transplantation. HBV transmission is caused by one of two types virus: the HBV 1 gene (the most common) or the HBV 2 gene (very rare). 1 is transmitted through contact with blood, whereas HBV 2 is transmitted by contact with infected mother during pregnancy. According to the Centers for Disease Control and Prevention (CDC), one in eight people infected with HBV is likely to develop chronic HBV infection (chronic liver disease) and about 20,000 people die each year of cirrhosis and liver cancer caused by HBV infection. About Interferon Interferon beta-1a is a licensed and safe interferon that is used to treat hepatitis C virus (HCV) and acute hepatitis B virus (HBV) in patients with active infection. Interferon beta-1a is in the same class of medications as interferon beta-1a, including vidarabine (Remicade), and it belongs to a class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs treat hepatitis C by interfering with.

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