weixin.sogou.com·· 12 hours agoPickScore86
FDA Approves GSK's Bepirovirsen Plus Nucleos(t)ide Therapy for Chronic Hepatitis B in Adults Without Cirrhosis
In brief
On October 20 local time, the FDA approved GSK's bepirovirsen in combination with nucleos(t)ide analogues for eligible adults with chronic hepatitis B and no cirrhosis, given as a 6-month course. The two global Phase 3 trials, B-Well 1 and B-Well 2, covered 29 countries and 1838 chronic hepatitis B patients already on nucleos(t)ide therapy; after 24 weeks of treatment and follow-up to 72 weeks, the overall functional cure rate was 19% (233/1220), with no placebo recipients achieving it.
Why it matters
Pools functional cure rates from two global Phase 3 trials and discloses boxed warning and severe adverse event comparisons, giving direct evidence on benefit and risk.
Source: weixin.sogou.com · weixin.sogou.com