FDA Grants Approval for GSK's Hepatitis B Treatment, Hibsago

The FDA has approved GSK and Ionis' bepirovirsen, now named Hibsago, for chronic hepatitis B in certain adult patients. This first-in-class antisense oligonucleotide aims for a functional cure, a significant advance over existing therapies. The approval, which came earlier than anticipated, includes a black box warning for two risks.