Oct 20 (Reuters) – 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.
In clinical trials, bepirovirsen helped nearly one-in-five patients achieve undetectable levels of the hepatitis B virus and remain off antiviral treatment for at least six months.
Hepatitis B is a serious liver infection that can lead to liver damage and cirrhosis, or scarring of the liver. The virus spreads through infected bodily fluids such as blood, saliva and semen.
More than 250 million people globally live with chronic hepatitis B, and current standard-of-care treatments help only 1% to 4% of patients clear the virus for a sustained period, or achieve what doctors call a functional cure.
Nucleotide analogues, a widely used class of hepatitis B treatments, are often taken for life and suppress the virus but rarely eliminate it.
US biotech Aligos Therapeutics is developing a rival hepatitis B therapy, pevifoscorvir sodium, which is being evaluated in a mid-stage trial.
GSK did not immediately respond to a Reuters request for comment on US pricing and commercial availability.
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(Reporting by Padmanabhan Ananthan in Bengaluru and Bhanvi Satija in London; Editing by Diti Pujara)
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