Policy & Regulation
GSK's bepirovirsen granted Fast Track designation by FDA for chronic hepatitis B
12 February 2024 -

Biopharma company GSK (LSE: GSK) (NYSE: GSK) announced on Monday that it has secured Fast Track designation from the US FDA for bepirovirsen, an investigational antisense oligonucleotide (ASO) targeting chronic hepatitis B (CHB).

The designation expedites drug development for serious conditions with unmet medical needs. Bepirovirsen's potential was supported by phase IIb trials B-Clear and B-Sure, with ongoing phase III program B-Well.

CHB affects nearly 300 million people globally, with current treatments offering a less than 2-8% functional cure rate.

Bepirovirsen is in phase III development, showing promise for a clinically meaningful functional cure response when combined with oral nucleoside/nucleotide analogues.