LONDON (dpa-AFX) - GSK plc (GSK) announced that the US Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) to treat chronic hepatitis B (CHB) virus infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NrtI) therapy in adult patients without cirrhosis.
The approval covers patients who have received NrtI therapy for at least six months, have suppressed hepatitis B virus (HBV) DNA levels, and have hepatitis B surface antigen (HBsAg) levels of 3,000 IU/mL or less, as determined by an FDA-authorized test.
The FDA approval was backed by Phase 3 B-Well trial results showing a 19% functional cure rate in eligible patients treated with bepirovirsen, compared with less than 1% typically achieved with standard-of-care therapy alone after one year.
Functional cure, a key goal in chronic hepatitis B treatment, is defined as undetectable levels of HBV DNA and HBsAg for at least 24 weeks after treatment cessation, indicating durable immune control without medication.
Bepirovirsen is an antisense oligonucleotide (ASO) designed to inhibit HBV RNA production, a key driver of chronic infection, with the goal of helping the immune system regain control of the virus.
According to GSK, bepirovirsen demonstrated functional cure rates that exceeded those typically observed with the current standard of care.
Hibsago is administered over a six-month treatment period, with patients having the option to self-administer the therapy after receiving the initial dose under healthcare supervision.
The FDA approved the therapy under Priority Review and Breakthrough Therapy Designation, designations intended for treatments that may offer significant advantages over available standard-of-care options.
GSK licensed bepirovirsen from Ionis and collaborated with them on its development. GSK continues to advance regulatory submissions for bepirovirsen across multiple geographies, with key regulatory decisions anticipated in the coming months.
GSK has traded between $42.85 and $61.70 over the past 52 weeks. The stock closed Tuesday's trade at $50.63, up 2.37%.
In after-hours trading, GSK is further up 0.14% at $50.70.
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