WeChat· 多肽圈·· 10 hours agoPickScore86
FDA Approves GSK Antisense Oligonucleotide Bepirovirsen for Chronic Hepatitis B
In brief
GSK's antisense oligonucleotide drug bepirovirsen has received FDA approval for chronic hepatitis B, granted through the priority review pathway with breakthrough therapy designation. Pooled B-Well data show a 19% functional cure rate (233/1220) in the overall population after 6 months of treatment, versus 0 (0/614) in the placebo group.
Why it matters
FDA approval based on B-Well data showing 19% functional cure with bepirovirsen versus 0 with placebo in the overall chronic hepatitis B population.
Source: WeChat · mp.weixin.qq.com