GSK announced that Health Canada approved Hibsago (bepirovirsen) to treat chronic hepatitis B (CHB) infection. It is the first and only finite therapy indicated to achieve a functional cure in certain adults with the condition.
Health Canada granted the approval under its Priority Review policy, which is reserved for innovative treatments that could address significant unmet medical needs.
An estimated 262,000 people in Canada live with CHB, a leading cause of liver cancer. The approval was based on Phase III B-Well clinical trial data, which demonstrated clinically meaningful functional cure rates.