GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B
GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation aims to streamline the drug development process and accelerate the review of medications targeting severe conditions with unmet medical requirements.
The request for designation was made due to the promising potential of bepirovirsen in tackling an urgent medical necessity for CHB, a severe and potentially fatal condition. Evidence from the B-Clear and B-Su...