Novo Nordisk A/S: Wegovy® recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function

诺和诺德A/S：欧洲监管机构推荐Wegovy®进行标签更新，以反映心力衰竭症状的减轻和身体机能的改善

Wegovy® recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function Wegovy® (semaglutide 2.4 mg) is the first obesity medication to receive a positive opinion recommending a label update that reflects reduced symptoms and improved physical limitations and exercise function in people with obesity-related heart failure with preserved ejection fraction (HFpEF).The positive opinion is based on results from the STEP HFpEF and STEP HFpEF-DM trials, which showed that Wegovy® is an effective therapy compared to placebo for people with obesity-related HFpEF.1,2 Bagsværd, Denmark, 19 September 2024 – Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy® (semaglutide 2.4 mg) label in the European Union (EU).

欧洲监管机构推荐Wegovy®进行标签更新，以反映心力衰竭症状的减轻和身体机能的改善Wegovy®（semaglutide 2.4 mg）是第一种获得积极意见的肥胖药物，建议进行标签更新，以反映出射血分数（HFpEF）保持不变的肥胖相关心力衰竭患者的症状减轻，身体限制和运动功能得到改善。积极的意见是基于STEP HFpEF和STEP HFpEF DM试验的结果，该试验表明，与安慰剂相比，Wegovy®对于肥胖相关HFpEF患者是一种有效的治疗方法。1,2 Bagsværd，丹麦，2024年9月19日-诺和诺德今天宣布，欧洲药品管理局（EMA）人类使用药品委员会（CHMP）对欧盟（EU）中Wegovy®（semaglutide 2.4 mg）标签的更新持积极意见。

The label update incorporates data showing that Wegovy®, when added to standard of care, can reduce heart failure-related symptoms and improve physical limitations and exercise function in people with obesity-related HFpEF, with or without type 2 diabetes.1,2 The positive opinion is based on the results from the STEP HFpEF and STEP HFpEF-DM trials conducted in people with obesity-related HFpEF, with or without type 2 diabetes.

标签更新包含的数据显示，当添加到护理标准中时，Wegovy®可以减少与肥胖相关的HFpEF患者（有或没有2型糖尿病）的心力衰竭相关症状，改善身体限制和运动功能。1,2积极的意见是基于STEP HFpEF和STEP HFpEF DM试验的结果，这些试验是在肥胖相关的HFpEF患者中进行的，有或没有2型糖尿病。

1,2 In both trials, Wegovy® demonstrated greater reductions in heart failure-related symptoms and greater improvements in physical limitations, as measured by the patient-reported Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), alongside greater weight loss compared to placebo.1,2 The beneficial effects were consistent regardless of baseline age, sex, race, ethnicity, body mass index (BMI), region, systolic blood pres.

1,2在这两项试验中，根据患者报告的堪萨斯城心肌病问卷临床总结评分（KCCQ-CSS），Wegovy®表现出心力衰竭相关症状的更大减少和身体限制的更大改善，以及与安慰剂相比更大的体重减轻。1,2无论基线年龄，性别，种族，种族，体重指数（BMI），地区，收缩压如何，有益效果都是一致的。