US FDA approves GSK's hepatitis B drug, offering patients chance to stop long-term treatment

The US FDA said on Tuesday it had approved British drugmaker GSK's hepatitis B drug Hibsago, allowing patients with the liver infection a way to keep the virus under control after stopping treatment.The drug, chemically known as bepirovirsen, is the first FDA-approved antisense oligonucleotide for chronic hepatitis B, according to the agency.

Under new CEO Luke Miels, GSK is aiming to speed up the develop and launch of new medicines ahead of looming patent expirations on its blockbuster HIV drugs. The company expects ​peak annual sales of more than £2 billion ($2.68 billion) for the drug and is central to its plans to reach more than £40 billion in annual revenue by 2031.

Hibsago has already secured approval in Japan and is under regulatory review in China and Europe. The drug was licensed from rare disease drugmaker Ionis Pharmaceuticals, which is eligible to receive milestone payments upon approval and other regulatory benchmarks.