US FDA approves GSK's hepatitis B drug, letting patients end long-term treatment

The US FDA approved GSK's hepatitis B drug Hibsago on Tuesday, enabling patients to control the virus after stopping treatment. It is the first approved antisense oligonucleotide for chronic hepatitis B. The drug, chemically known as bepirovirsen, is central to GSK's strategy under CEO Luke Miels to accelerate new medicine launches ahead of HIV drug patent expirations. GSK projects peak annual sales exceeding £2 billion. Hibsago has already received approval in Japan and is under review in China and Europe. Licensed from Ionis Pharmaceuticals, the drug triggers milestone payments to Ionis upon regulatory achievements.