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Hibsago (bepirovirsen) approved in the US for the treatment of chronic hepatitis B (CHB) | GSK
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Approval based on phase III data showing unprecedented functional cure rates compared to standard of care
Six-month treatment with option of self-administration after first dose
CHB affects approximately 1.7 million people in the US1
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis, receiving Nrtl therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid (DNA), and with hepatitis B virus (HBV) surface antigen (HBsAg) levels ≤3000 IU/ml, as determined by an FDA-authorised test.2 Bepirovirsen is a first in class antisense oligonucleotide (ASO) and offers unprecedented functional cure rates compared to current standard of care. The approval was granted under FDA priority review and Breakthrough Therapy Designation, recognising significant improvement of bepirovirsen and nucleos(t)ide analogue therapy over existing standard of care.3
https://www.gsk.com/en-gb/media/press-releases/hibsago-bepirovirsen-approved-in-the-us-for-the-treatment-of-chronic-hepatitis-b-chb/
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