The FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B in adults without cirrhosis who have suppressed HBV DNA and surface antigen levels ≤3000 IU/ml. GSK licensed bepirovirsen from Ionis in 2019 under a collaborative agreement that entitles Ionis to tiered royalties of 10-12% on net sales, along with potential milestone payments. The approval follows Phase 3 B-Well trials demonstrating functional cure rates of 19%. Ionis is a biotechnology company focused on discovering and developing RNA-targeted medicines for serious diseases.
