Global healthcare giant GSK has announced that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for bepirovirsen, an investigational antisense oligonucleotide (ASO) for adults with chronic hepatitis B (CHB).
Chronic hepatitis B remains a major public health concern in Europe, affecting an estimated 3.2 million people. Current treatments, including nucleos(t)ide analogues, “often require lifelong therapy and the functional cure rates remain low, typically only 1%.”
Functional cure is defined as the virus being undetectable for at least 24 weeks after stopping all treatment, indicating immune control without medication. CHB is also a leading cause of liver cancer, accounting for roughly 56% of cases globally.
The EMA submission is supported by positive results from GSK’s Phase III B-Well 1 and B-Well 2 trials. Both studies “met their primary endpoint, and bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate.”
Patients receiving bepirovirsen plus standard care showed “functional cure rates significantly higher… compared with standard of care alone,” with even greater effects in those with baseline surface antigen (HBsAg) ≤1000 IU/ml. The trials also confirmed “an acceptable safety and tolerability profile consistent with what was reported in other studies.”
