GSK's Hibsago Gets US FDA Approval for Chronic Hepatitis B

03:45 AM EDT, 10/21/2026 (MT Newswires) -- GSK (GSK) said Tuesday the US Food and Drug Administration approved its drug, Hibsago, or bepirovirsen, for adults without liver cirrhosis whose hepatitis B is controlled by standard antivirals but who still carry low levels of the virus's surface protein. In two phase 3 trials, 19% of patients cleared the virus enough to stop all treatment and remain virus-free for at least 24 weeks, the company said. The rate reached 26% among patients with the lowest starting levels of surface protein, a group making up about 45% of diagnosed cases worldwide, while standard care alone usually clears the virus in under 1% after a year, GSK said. Treatment runs six months, and patients can inject themselves after the first dose, while the most common side effects were injection site reactions, fever, fatigue and headache, it said.