GSK, Ionis hepatitis B functional cure breaks open market for followers

GSK and Ionis' antisense oligonucleotide Hibsago (bepirovirsen) received FDA approval, becoming the first antisense oligonucleotide approved for chronic hepatitis B and offering a functional cure option. The approved indication is limited to adults without liver damage who have received nucleos(t)ide analogue therapy for at least six months, have suppressed HBV DNA and HBsAg below a threshold, and requires use with a Roche companion diagnostic.