The U.S. Food and Drug Administration approved GSK plc's Hibsago (bepirovirsen) injection on Tuesday for adults with chronic hepatitis B who do not have cirrhosis. The approval followed priority review and Breakthrough Therapy Designation. Patients receive the injection subcutaneously each week. Eligible patients must have received antiviral treatment for at least six months, have suppressed viral DNA and have surface antigen (HBsAg) levels no higher than 3,000 IU/mL.
The FDA also approved the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic for patient selection and monitoring. Chronic hepatitis B produces a persistent liver infection that raises the risk of cirrhosis and liver cancer. Hibsago is a first-in-class antisense oligonucleotide. Hibsago blocks genetic instructions used by the hepatitis B virus for replication and viral protein production, lowering circulating virus and antigen levels.
The approval rests on results from the B-Well 1 and B-Well 2 phase 3 trials. Across the trials, 24% of participants receiving Hibsago for 24 weeks alongside existing antiviral medicine could stop baseline medication. No participants in the placebo group could stop baseline medication. At 24 weeks after all treatments ended, 19% of Hibsago patients, or 233 of 1,220, maintained a functional cure. A functional cure meant that viral DNA and HBsAg remained undetectable. The placebo group recorded no functional cures. Standard care alone typically produces a functional cure rate below 1% after one year.
Participants whose baseline antigen levels did not exceed 1,000 IU/mL achieved a functional cure rate of 26%, or 200 of 768. Patients within that antigen range represent about 45% of cases worldwide. Exploratory findings at week 72 showed that 49% of participants overall had lowered surface antigen levels to no more than 100 IU/mL.
Hibsago carries a boxed warning about serious liver reactions and low platelet counts that increase bleeding risk. Regulators also warned about declining kidney function, inflammatory reactions such as vasculitis and risks from incorrect administration.
Benzinga Pro data showed GSK shares down 0.75% at $50.25 at publication on Wednesday.
GSK Wins FDA Approval for Chronic Hepatitis B Drug Hibsago
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Summary
GSK's Hibsago (bepirovirsen) injection received FDA approval for adults with chronic hepatitis B without cirrhosis. The first-in-class antisense drug secured priority review and Breakthrough Therapy status. In trials, 24% of patients stopped baseline antiviral meds after 24 weeks, and 19% achieved a functional cure, versus 0% in the placebo group. Traders using TA for crypto may look for support and resistance levels amid market reactions. The drug carries warnings for severe liver reactions, low platelet counts, and other risks.
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