GSK submits bepirovirsen for EMA review after trials hit primary endpoints

27th Mar 2026 08:15

(Sharecast News) - Drugmaker GSK said on Friday that the European Medicines Agency will review its marketing authorisation application for the use of bepirovirsen, an investigational antisense oligonucleotide, in the treatment of adults with chronic hepatitis B.

GSK said the regulatory submission to the EMA was based on positive results from its B-Well 1 and B-Well 2 Phase III trials - both of which met their primary endpoint, with bepirovirsen demonstrating a "statistically significant and clinically meaningful" functional cure rate.

The FTSE 100-listed firm noted that chronic hepatitis B remains a "public health concern" in Europe, with an estimated 3.2m people living with the condition. It also highlighted that the current standard of care, nucleos(t)ide analogues, often requires lifelong therapy and said the functional cure rate remains at typically only 1%.

GSK added that bepirovirsen was also being evaluated as a potential backbone therapy for future sequential treatment strategies aimed at expanding functional cure to broader patient populations. It has yet to be approved anywhere in the world.

As of 0815 GMT, GSK shares were down 0.34% at 2,040p.

Reporting by Iain Gilbert at Sharecast.com

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