mp.weixin.qq.com·· 10 hours agoPickScore79
FDA Approves Bepirovirsen Plus NrtI for Certain Non-Cirrhotic Adults With Chronic Hepatitis B
In brief
The FDA has approved the antisense oligonucleotide bepirovirsen (brand name Hibsago) in combination with NrtIs for certain adults with chronic HBV infection who do not have cirrhosis. It is the first ASO approved by the FDA for chronic hepatitis B, and reports say the therapy is under priority review in China.
Why it matters
The approval defines the scope for bepirovirsen plus NrtI in non-cirrhotic adults with HBV and sets a regulatory reference for similar ASO reviews.
Source: mp.weixin.qq.com · mp.weixin.qq.com