CHINESE AUTHORITIES APPROVE TREATMENT FOR HEPATITIS B

Idenix Pharmaceuticals announced that Sebvio has received approval from the Chinese State Food and Drug Administration as a once-a-day treatment for chronic hepatitis B. Hepatits B affects more than 100 million people in China, according to the company. Idenix expects the drug to become available in April.

Sebvio (telbivudine), which is called Tyzeka in the U.S., received FDA approval in October 2006. The drug has also been approved in Canada, Australia, Switzerland and several countries in Asia and Latin America. Sebvio also recently received a positive opinion recommending approval from the European Medicines Agency.

The approvals have been based primarily on one-year data from the GLOBE study, the largest worldwide registration trial including both hepatitis B patients that are e-antigen-positive and e-antigen-negative, and the first to include patients in China, according to the company. The study results demonstrated that telbivudine provided potent viral suppression and high rates of polymerase chain reaction negativity after one year. An additional Phase III trial in China corroborated these findings and supported the Chinese application.