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FDA grants Fast Track designation to GSK’s chronic hepatitis B treatment
GSK has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB).
The designation was requested as the drug has a potential to address an unmet medical need for CHB, and follows data from the phase 2b trials B-Clear and B-Sure, both of which assessed the efficacy, safety and durability of the response of the drug in patients with CHB. The confirmatory phase 3 programme, B-Well, is currently taking place.
According to the company’s press release: ‘Bepirovirsen is the only single agent in phase 3 development that has shown the potential to achieve clinically meaningful functional cure response when combined with oral nucleoside/nucleotide analogues (NAs)’.
The press release continues: ‘This was demonstrated by positive results in the B-Clear and B-Sure clinical trials. B-Clear identified that patients with low baseline hepatitis B surface antigen levels are most likely to benefit from treatment with bepirovirsen. Bepirovirsen is also being investigated as a potential backbone therapy in future sequential regimens to pursue functional cure in a broader population of patients with CHB’.
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