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GSK Obtains First Global Approval for Chronic Hepatitis B Drug Hibsago

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GSK Obtains First Global Approval for Chronic Hepatitis B Drug Hibsago

GSK (GSK.L) secured the first global approval for Hibsago, or bepirovirsen, after Japan's Ministry of Health, Labour and Welfare cleared the drug as a functional cure for adult patients with chronic hepatitis B virus infection.

The approval is specific for the administration of the antisense oligonucleotide in patients who underwent at least six months of nucleos(t)ide analogue therapy and meet pre-defined viral markers, according to a Monday filing. The UK-based pharmaceutical group used data from the phase 3 B-well trials to support the application for Hibsago in Japan, where the drug had also received a SENKU fast-track designation prior to approval in recognition of its potential to address high unmet medical need.

"For the first time, a treatment approved for functional cure is available to people living with chronic hepatitis B in Japan with Hibsago. After 6-months of treatment with Hibsago, patients could be freed from life-long therapy and reduce their risk of long-term liver complications. This is a major advance for CHB management and our innovative hepatology portfolio, and we look forward to further regulatory decisions in other countries," said Chief Scientific Officer Tony Wood.

GSK said it is advancing regulatory submissions for bepirovirsen in other jurisdictions, with decisions expected in the coming months in geographies including the US.

In another project, GSK also flagged the US Food and Drug Administration's acceptance for priority review of its supplemental biologics license application for Jemperli, or dostarlimab, as a treatment for previously untreated stage II and III mismatch repair deficient locally advanced rectal cancer.

The application is based on results from the phase 2 Azur-1 trial, which showed a significant proportion of participants having no detectable signs of cancer one year or more after treatment.

GSK shares declined marginally in early morning trading.

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