Idenix: Telbivudine approved in Switzerland for chronic hepatitis B

By E. Janene Geiss

Philadelphia, Sept. 21 - Idenix Pharmaceuticals, Inc. said Thursday that the Swissmedic has approved telbivudine as a new treatment for chronic hepatitis B 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, the Cambridge, Mass., biopharmaceutical company said in a news release.

A New Drug Application was submitted by Idenix with the Food and Drug Administration 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. Telbivudine will be called Sebivo in Switzerland.

The drug is being developed by Idenix and Novartis Pharma AG under a development and commercialization arrangement established in May 2003 along with another hepatitis B clinical product candidate, valtorcitabine.

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