GSK’s antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, will get a rapid six-month review from the FDA when it is filed for approval, said the drugmaker this morning.
The fast-track designation from the US regulator recognises that bepirovirsen is the only single agent in phase 3 that has shown the potential to achieve a “functional cure” when combined with standard CHB therapies based on oral nucleoside or nucleotide analogue (NA) drugs, according to GSK.
