FDA Approves New Treatment for Chronic Hepatitis B Virus

The U.S. FDA has approved bepirovirsen (Hibsago, GSK) for treating chronic hepatitis B virus (HBV) infection in adult patients without cirrhosis. This first-in-class antisense oligonucleotide, granted priority review and Breakthrough Therapy designation, is for use with existing nucleoside/nucleotide analog therapy and showed functional cure rates in Phase 3 trials.