GSK Wins FDA Approval for Hepatitis B Therapy With Cure Potential

The U.S. Food and Drug Administration (FDA) approved GSK’s Hibsago (bepirovirsen) to treat chronic hepatitis B (CHB) in certain adults. The first-in-class antisense oligonucleotide (ASO) therapy offers a new approach for an estimated 1.7 million people in the U.S. living with the disease.

Hibsago is the first treatment with the potential to provide a functional cure, which could allow patients to stop long-term therapy. The FDA granted approval under Priority Review and Breakthrough Therapy Designation.

The approval was based on Phase III trials. In eligible patients, a six-month course achieved a 19% functional cure rate, significantly higher than with standard of care.