U.S. FDA· FDA·· 3 hours agoPickScore97
FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment
In brief
The FDA has approved Hibsago (bepirovirsen) injection, combined with existing antiviral therapy, to treat chronic hepatitis B in certain adults without cirrhosis. Hibsago is the first FDA-approved antisense oligonucleotide for chronic hepatitis B.
Why it matters
Placebo-controlled data quantify the proportion of patients maintaining viral control after stopping therapy, and the boxed warning identifies serious liver reactions and low platelet counts requiring monitoring.
Source: U.S. FDA