Telbivudine Approved in Switzerland for Chronic Hepatitis B
This is great news for all those suffering from the Hep B disease. IMHO, China needs to push this approval hard. I have several coworkers in our Shanghai office whom suffer from this illiness.
Thursday September 21, 1:15 am ET
CAMBRIDGE, Mass., Sept. 21 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), announced today 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.(1)
We are committed to improving the therapeutic options for patients with viral diseases with new drugs, such as telbivudine," said Jean-Pierre Sommadossi, chairman and chief executive officer of Idenix. "For Idenix, this is a major milestone as it is the first approval of Idenix's first drug candidate, telbivudine, in a European country, just 6 years after it entered clinical development. Having achieved this milestone is an inflection point in Idenix's evolution to a fully integrated pharmaceutical company."
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.
Safety Information About Telbivudine
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.
About Chronic Hepatitis B
Approximately 350 million people worldwide are living with CHB,(2) a virus which affects the liver, and is 50 to 100 times more infectious than the human immunodeficiency virus (HIV).(2) Hepatitis B is the second most common cause of cancer after smoking,(2) and each year an estimated 1.2 million people worldwide die from hepatitis B-related chronic liver disease.(3)
Idenix/Novartis Collaboration
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 US, France, Germany, Italy, Spain and the UK. 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.
