Sebivo® (telbivudine), a new treatment for patients with chronic hepatitis B co-developed by Idenix Pharmaceuticals, Inc. (IDIX) and Novartis Pharma AG (NVS), has been approved in Swizerland.
This approval is based primarily on one-year data from the GLOBE study, the largest worldwide registration trial ever conducted in patients with chronic hepatitis B.
A single pill taken orally once daily with or without food, Sebivo has been shown to effectively suppress replication of the hepatitis B virus.
"Telbivudine's demonstrated ability to drive down virus levels in the first six months of treatment, along with its favorable safety and convenience profile in clinical trials to date, make it a promising treatment option for patients."
Applications for regulatory approval have also been filed with the US Food and Drug Administration as well as with the European Medicines Agency (EMEA) and the Chinese health authority.
Further details of the GLOBE study and the Swiss approval are discussed in this press release.
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