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FDA approves Hibsago for chronic hepatitis B with 19% functional cure rate
GSKGSK plc
The US FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B in adults without cirrhosis who have suppressed viral DNA and surface antigen levels ≤3000 IU/ml. The approval is based on phase III B-Well trial data showing a 19% functional cure rate after six months of treatment, compared to less than 1% with standard care alone. A secondary analysis showed a 26% cure rate in patients with lower baseline antigen levels (≤1000 IU/ml). GSK licensed the first-in-class antisense oligonucleotide from Ionis Pharmaceuticals and will continue pursuing regulatory approvals globally. GSK is a global biopharmaceutical company focused on vaccines, specialty medicines, and consumer healthcare.