GSK Hibsago Becomes First ASO Approved for Chronic Hepatitis B

Hibsago becomes the first ASO approved for chronic hepatitis B, giving patients a new option to control the virus after stopping treatment.

The U.S. Food and Drug Administration clears the British drugmaker’s therapy, chemically known as bepirovirsen, marking a milestone for people living with the liver infection.

GSK positions the medicine as a key growth driver under new CEO Luke Miels, with expected peak annual sales exceeding £2 billion.

The approval comes as the company races to launch innovative medicines ahead of patent losses in its HIV portfolio and targets more than £40 billion in annual revenue by 2031. Hibsago already holds approval in Japan and faces reviews in China and Europe.

FDA Clears First-in-Class Therapy

The U.S. Food and Drug Administration announces approval of GSK’s hepatitis B drug Hibsago on Tuesday. The agency recognizes bepirovirsen as the first FDA-approved antisense oligonucleotide for chronic hepatitis B.

This designation gives patients a new way to manage the infection and maintain viral control once they discontinue therapy. GSK licenses the drug from Ionis Pharmaceuticals. Ionis becomes eligible to receive milestone payments upon approval and additional regulatory benchmarks.

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Strategic Importance for GSK

Under new CEO Luke Miels, GSK accelerates the development 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 Hibsago.

The therapy forms a central part of GSK’s plan to reach more than £40 billion in annual revenue by 2031. Hibsago has already secured approval in Japan. Regulatory authorities in China and Europe currently review the medicine for potential authorization.

Addressing a Persistent Medical Need

Chronic hepatitis B remains a serious liver infection that requires long-term management for many patients. The new treatment offers a distinct approach by using antisense oligonucleotide technology. This mechanism helps patients achieve sustained control of the virus even after they stop taking the drug.

GSK continues to expand its pipeline of innovative therapies. The approval of Hibsago strengthens the company’s position in infectious diseases and supports its broader ambition to deliver high-value medicines that improve patient outcomes while driving long-term growth.

The clearance of this first-in-class ASO underscores GSK’s focus on scientific progress and commercial execution as it navigates a period of portfolio transition.