GSK, Ionis win FDA approval for first-of-its-kind hepatitis B drug

· Health · United Kingdom · United States

GSK and Ionis have received FDA approval for bepirovirsen, now branded Hibsago, a chronic hepatitis B drug described as first-of-its-kind and a potential functional cure for the infection. The approval came earlier than expected, according to Endpoints News, and the drug is seen as capable of reaching blockbuster status. STAT reported that the medicine extended functional cures to far more patients than previous methods. Hibsago is viewed as an important part of GSK's goal of reaching £40 billion in annual revenue by 2031. The decision gives the British drugmaker a new asset in a field where existing treatments rarely clear the virus, and hands Ionis a partner-backed commercial product.

Why it matters：A functional cure for chronic hepatitis B would shift treatment standards in a large patient population and intensify competition among developers of nucleic acid-based therapies.

Key points

  • The drug is bepirovirsen, marketed as Hibsago.
  • FDA approval arrived earlier than expected, Endpoints reported.
  • The drug is viewed as an important part of GSK's £40 billion revenue goal by 2031.

Sources (original reporting)

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