FDA approves GSK's Hibsago, first hepatitis B drug with 'functional cure'
The FDA has approved GSK's Hibsago (bepirovirsen) injection for chronic hepatitis B. In the B-Well trials, 19% of patients achieved a functional cure after a six-month course, versus less than 1% on standard care.
- 19% of patients achieved functional cure versus under 1% on standard care
- Treatment lasts six months, with self-administration possible after the first dose
- Approval granted under Priority Review and Breakthrough Therapy Designation
- Chronic hepatitis B affects more than 250 million people worldwide
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