GSK secures US approval for hepatitis B drug Hibsago.
Drugmaker GSK said on Wednesday that the US Food and Drug Administration had approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B in adults without cirrhosis, marking the first approval of an antisense oligonucleotide for the disease.
Source: Sharecast
GSK said the drug was cleared under priority review and breakthrough therapy designation, with the regulator recognising its ability to deliver functional cure rates far above the current standard of care.
The FTSE 100-listed firm stated the decision was underpinned by phase III B‑Well data showing a 19% functional cure rate in adults, compared with less than 1% typically achieved after a year of existing therapy.
Exploratory analyses showed bepirovirsen reduced HBsAg to ≤100 IU/ml in 49% of the overall study population and 62% of those in the ≤1000 IU/ml subgroup, levels associated in medical literature with improved immune control.
GSK highlighted that quantitative HBsAg testing will help identify eligible patients and noted that several FDA‑authorised tests were already available. It also stated it was advancing regulatory submissions in multiple geographies, with further decisions expected in the coming months.
As of 1005 BST, GSK shares were down 0.24% at 1,864p.
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