Idenix Pharmaceuticals Inc. announced that Sebivo (telbivudine) has received approval from the Chinese State Food and Drug Administration (SFDA) as a once-a-day treatment, taken orally with or without food, for the treatment of chronic hepatitis B (CHB).

CHB remains a significant global health care concern, particularly in China where it affects more than 100 million people (1-3) - representing about one-third of those infected worldwide. Sebivo is expected to be available in China in April.

"The Chinese approval of telbivudine is positive news for the many CHB patients in China," said Dr Calvin Q. Pan, MD, director, Clinical Research Hepatology, Mount Sinai Services at Elmhurst Hospital in New York City. "As a physician who treats many CHB patients in the US, it is good to know that the patients in China will also have access to this new treatment option. Now, Chinese patients may also benefit from telbivudine's ability to provide early viral suppression, a primary goal of treatment."

Telbivudine received regulatory approval in the United States from the Food and Drug Administration (FDA) in October 2006 for the treatment of CHB in adult patients with evidence of viral replication and active liver disease. Telbivudine is called Tyzeka in the United States and is called Sebivo in all other countries. The approval of Sebivo in China follows earlier approvals in Canada, Australia, Switzerland and several countries in Asia and Latin America. Sebivo also recently received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommending approval by the European Commission.

Worldwide regulatory submissions have been based primarily on one-year data from the GLOBE study, the largest worldwide registration trial including hepatitis B e-antigen (HBeAg)-positive and HBeAg-negative patients with CHB, and the first to include patients from China. The study results demonstrated that telbivudine provided potent viral suppression and high rates of PCR- negativity after one year. An additional Chinese phase III trial, involving 332 adult Chinese patients with CHB, corroborated these findings and supplemented the filing in China.