FDA Approves GSK Hepatitis B Drug

The US FDA has approved GSK's Hibsago for chronic hepatitis B, marking the first antisense oligonucleotide for the liver infection. The treatment could allow patients to stop long-term therapy while keeping the virus suppressed, supporting the drugmaker's growth targets.

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Signage is pictured in the main lobby of GSK offices in London, Britain, February 20, 2025. REUTERS/Chris J. Ratcliffe

The United States Food and Drug Administration approved GSK PLC-SPON ADR's hepatitis B drug Hibsago on Tuesday morning, allowing patients to keep the liver infection suppressed after stopping treatment. The approval marks the first antisense oligonucleotide authorized for chronic hepatitis B in the country. The treatment is central to the United Kingdom-based drugmaker's strategy to reach more than £40 billion in annual revenue by 2031.

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