8月15日,诺和诺德宣布司美格鲁肽(Wegovy)的补充新药申请(sNDA)获FDA批准,用于结合减少卡路里饮食和增加体力活动治疗伴有中晚期肝纤维化(F2期或F3期)的代谢功能障碍相关性脂肪性肝炎(MASH)患者。MASH一直是GLP-1制剂争夺的重要适应证。CIC灼识咨询董事总经理刘立鹤此前对《每日经济新闻》记者表示:“MASH的发病机制复杂,相关监管部门对新药临床试验终点的评判标准也极为严格。...
Source Link8月15日,诺和诺德宣布司美格鲁肽(Wegovy)的补充新药申请(sNDA)获FDA批准,用于结合减少卡路里饮食和增加体力活动治疗伴有中晚期肝纤维化(F2期或F3期)的代谢功能障碍相关性脂肪性肝炎(MASH)患者。MASH一直是GLP-1制剂争夺的重要适应证。CIC灼识咨询董事总经理刘立鹤此前对《每日经济新闻》记者表示:“MASH的发病机制复杂,相关监管部门对新药临床试验终点的评判标准也极为严格。...
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