FDA Approves GSK Antisense Oligonucleotide Bepirovirsen for Chronic Hepatitis B

GSK announced that the antisense oligonucleotide bepirovirsen has received FDA approval, in combination with nucleos(t)ide analogue reverse transcriptase inhibitors, for the treatment of chronic hepatitis B. Phase III studies showed a functional cure rate of 19%. The drug targets hepatitis B virus-related RNA to lower HBsAg levels and induce a durable immune response, offering a new treatment option toward functional cure.