GSK announces U.S. FDA accepted priority review, granted BTD for bepirovirsen

GSK (GSK) announced that the US Food and Drug Administration, FDA, has accepted for priority review a New Drug Application, NDA, for bepirovirsen, an investigational antisense oligonucleotide, ASO, for the treatment of adults with chronic hepatitis B, CHB. Bepirovirsen has also received Breakthrough Therapy Designation, BTD, which is reserved for investigational medicines where preliminary clinical evidence indicates the potential for substantial improvement over available therapies. The regulatory submission and BTD are supported by positive results from the Phase III B-Well 1 and B-Well 2 trials, where bepirovirsen demonstrated statistically significant and clinically meaningful functional cure rates.