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Home Industry News Novartis and Idenix seek European approval of telbivudine

Novartis and Idenix seek European approval of telbivudine

7th February 2006

Drugs giant Novartis and partner Idenix are seeking approval of chronic hepatitis B viral suppressant telbivudine from the European medical watchdog the Committee for Medicinal Products for Human Use.

Both firms said that the submission had been completed, based upon positive results of the drug’s phase III clinical trial. A submission to the US Food and Drug Administration (FDA) has also been filed.

The trial, which is ongoing, is taking place across the 112 clinics in 20 countries, including the United Kingdom and Greece. In its first year the study discovered that patients had responded well meeting expectations for the treatment.

“Telbivudine has shown the potential to set a standard of care for the treatment of patients with hepatitis B through rapid and sustained viral suppression,” said Dr James Shannon, of Novartis.

“The European filing is a significant step toward making this new treatment option available to more than three million patients estimated to be affected by the chronic hepatitis B virus in Europe.”

Chronic hepatitis B affects 350 million people worldwide, is often fatal, and stands as the tenth biggest killer worldwide, according to the World Health Organisation.

track© Adfero Ltd

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