GSK (GSK) announced on Monday that Japan's Ministry of Health, Labor and Welfare has approved the company's drug Hibsago, or bepirovirsen, as a functional cure for chronic hepatitis B virus infection in certain patients.

Adult patients who have received at least six months of prior nucleoside/nucleotide analogue therapy and who meet pre-defined viral markers are eligible to receive Hibsago.

This is the first global approval for Hibsago, and the first and only functional cure treatment for chronic hepatitis B approved in Japan, reported GSK, in a filing with the London Stock Exchange.

Chronic hepatitis B affects nearly one million people in Japan with nationwide efforts underway for screening and treatment, said GSK.

GSK said it continues to advance regulatory submissions for Hibsago in multiple nations, with decisions, including the US, expected in the coming months.