Swiss drugmaker Novartis has filed telbivudine, the company's treatment for chronic hepatitis B, for approval in China, based on recent study data that showed the drug was superior to the more commonly used lamivudine.
In Phase III trial conducted in China where more than 120 million people are currently infected with hepatitis B telbivudine demonstrated viral suppression. The drug has already been filed in the U.S. and EU.
"The results from this study are very promising," said Jinlin Hou,
lead investigator of the study and professor of hepatology at Nanfang Hospital
in Guangzhou, China. "Telbivudine displayed increased efficacy compared
to lamivudine on the key viral and clinical markers including significantly
greater viral suppression, a higher percentage of patients with normalization
of liver enzymes and a higher proportion of patients with HBeAg loss at one
year. These data suggest that telbivudine, if approved in China, may become
an important new treatment option for the millions of Chinese patients with
this potentially life-threatening disease."