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Idenix announces telbivudine for chronic hepatitis B patients approved in Switzerland
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Hepatitis Weekly - Oct. 16, 2006
2006 OCT 16 - (NewsRx.com) -- Idenix Pharmaceuticals, Inc. (IDIX), announced that the Swissmedic has approved telbivudine as a new treatment for chronic hepatitis B (CHB) in compensated patients with evidence of viral replication and active liver inflammation.
Telbivudine is a single pill taken orally, once a day, with or without food to suppress replication of hepatitis B virus (Hepatology. 2005; (42.S1):78A).
A new drug application was submitted by Idenix with the United States Food and Drug Administration (FDA) in late 2005 and is currently under review. Regulatory applications were submitted by Novartis in 2006 in a number of regions including the European Union, Canada, Australia, Switzerland, Taiwan, South Korea and China seeking marketing approval of telbivudine for the treatment of CHB. Telbivudine will be called Sebivo in Switzerland.
The diverse nature and rate of occurrence of adverse events were similar between telbivudine-treated patients and lamivudine-treated patients. The most common adverse events for telbivudine and lamivudine, regardless of attributability, were upper respiratory infection, headache, fatigue and nasopharyngitis.
Grade 3-4 serum ALT elevations were more common in lamivudine-treated patients compared to telbivudine after week 24. Grade 3-4 creatine kinase (CK) elevations were more common with telbivudine compared to lamivudine by week 52.
Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least one year in patients who discontinue anti-hepatitis B therapy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Telbivudine is being developed in collaboration between Idenix and Novartis Pharma AG under a development and commercialization arrangement established in May 2003, along with another hepatitis B clinical product candidate valtorcitabine. The collaboration arrangement further provides that Idenix and Novartis will co-promote telbivudine and valtorcitabine and other product candidates that Novartis has licensed, upon successful development and approval, in the U.S., France, Germany, Italy, Spain and the U.K. Novartis holds the exclusive license to commercialize telbivudine and valtorcitabine in the rest of the world. In March 2006, Novartis expanded its collaboration with Idenix to include valopicitabine, an investigational agent for the treatment of chronic hepatitis C.
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company focused on drugs for the treatment of human viral and other infectious diseases. Idenix's current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus.
This article was prepared by Hepatitis Weekly editors from staff and other reports. Copyright 2006, Hepatitis Weekly via NewsRx.com.
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