Shot in the arm for GSK as Americans clear hepatitis drug

By the Editorial Team · Thursday, October 22, 2026

The FDA has approved Hibsago, a new treatment from GlaxoSmithKline for certain chronic hepatitis B patients, marking a significant advancement with nearly 20 percent of treated patients achieving a functional cure in trials. This approval supports GSK’s growth ambitions amid upcoming patent expiries, although the treatment’s monitoring requirements may limit widespread adoption outside specialized care settings.

The US Food and Drug Administration (FDA) has approved Hibsago, a new treatment developed by GlaxoSmithKline (GSK) for certain patients with chronic hepatitis B (CHB). This regulatory clearance marks a significant milestone for the British pharmaceutical company as it seeks to bolster its product portfolio and meet an ambitious £40 billion sales target by 2031.

Hibsago, known chemically as bepirovirsen, is designed for chronic hepatitis B patients without cirrhosis who meet specified criteria. Chronic hepatitis B affects more than 240 million people worldwide and is a leading cause of liver cancer, contributing to approximately 1.1 million deaths annually. Current therapies offer limited chances of a “functional cure,” where the virus becomes undetectable in patients' blood, with cure rates generally between 1 and 2 percent.

Late-stage clinical trials of Hibsago demonstrated that nearly 20 percent of patients treated with the drug achieved this functional cure, a notable improvement over existing therapies. The treatment involves a six-month course with the option for patients to self-administer doses after the initial supervised one. Tony Wood, GSK’s chief scientific officer, emphasized the significance of the approval, highlighting the potential to reduce long-term liver complications and the burden of indefinite treatment for many patients.

Despite the promising efficacy data, Hibsago will include a boxed warning regarding risks such as hepatic flares and thrombocytopenia, necessitating close monitoring throughout the treatment period. Analysts from Jefferies noted that this monitoring requirement could complicate the treatment process and potentially slow uptake outside specialised hepatology settings, despite the convenience of self-administration.

GSK’s shares were largely unchanged at £18.68 following the announcement. The company, valued at around £75 billion, is one of the United Kingdom’s leading pharmaceutical firms alongside AstraZeneca. Last year, GSK’s total sales reached £32.7 billion, with its HIV drug dolutegravir generating £5.6 billion. However, the patent expiry of dolutegravir in 2028 poses a significant revenue challenge, increasing the pressure on new treatments like Hibsago to drive future growth.

Hibsago was previously approved in Japan in August and is currently under review by European and Chinese regulators. In related company news, Deborah Waterhouse, head of GSK’s HIV joint venture ViiV Healthcare with Japan’s Shionogi, announced her departure to lead Australian biotech company CSL as chief executive. Lynn Baxter, currently president of GSK’s European business, will succeed her at ViiV Healthcare.

This article was reported by synthesizing coverage from multiple independent news outlets to present a balanced, unbiased account. Read about our editorial standards. Spotted an error? Let us know.