FDA Approves Hibsago, the First Antisense Oligonucleotide Drug for Chronic Hepatitis B
The Food and Drug Administration on October 20 approved Hibsago (bepirovirsen, GSK) for the treatment of chronic hepatitis B, the first antisense oligonucleotide drug the FDA has approved for this indication.
The approval covers adults without cirrhosis who have been on antiviral therapy for at least six months, have suppressed HBV DNA, and have hepatitis B surface antigen (HBsAg) levels no higher than 3,000 IU/mL as measured by an FDA-authorized test. The FDA simultaneously authorized Roche's Elecsys HBsAg II quant II RxDx as a companion diagnostic. The drug had previously received Fast Track, Breakthrough Therapy, and Priority Review designations.
Hibsago is given by subcutaneous injection for up to 24 weeks, with prior antiviral therapy continued for at least 24 weeks after the last injection. In the phase 3 B-Well 1 and B-Well 2 trials, 24 percent of treated patients met criteria to stop their prior antiviral therapy, compared with 0 percent on placebo, and 19 percent maintained viral control with undetectable HBsAg 24 weeks after stopping all treatment. Wendy Carter, acting director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research, commented on the approval.
(Based on the FDA approval announcement)
Source: 食品药品监管局批准
Published by GSM · USA (original Chinese edition)
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