FDA批准双靶向2型糖尿病药物Mounjaro,它能帮助非糖尿病患者减重22.5%!

2022-05-16 Allan MedSci原创

礼来(Eli Lilly)最近报告了 SURMOUNT-1研究的结果,显示该药物帮助没有 2 型糖尿病的患者减轻了高达 22.5% 的体重。

FDA近日批准了礼来(Eli Lilly)每周一次的双重 GIP 和 GLP-1 受体激动剂 Mounjaro(tirzepatide),以改善成人2型糖尿病患者的血糖控制。FDA 糖尿病、脂质紊乱和肥胖药物评价和研究中心副主任 Patrick Archdeacon 说:“鉴于许多患者在实现目标血糖目标方面遇到的挑战,这项批准是 2 型糖尿病治疗的一个重要进展”。

在 III 期 SURPASS 计划中评估了三种不同剂量的治疗,涉及 10 项临床试验的 20,000 多名 2 型糖尿病患者,其中 5 项是全球注册研究。SURPASS-1 将 Mounjaro 与安慰剂进行对比,SURPASS-2 将其与诺和诺德每周一次的 GLP-1 激动剂 Ozempic(semaglutide)进行了头对头对比。

平均而言,随机接受 Mounjaro 15mg(最大推荐剂量)的患者在单独使用时成功地将其 HbA1c 水平降低了 1.6%,而与长效药物一起使用时,则比安慰剂降低了 1.5%。在将 Mounjaro 与其他糖尿病药物进行比较的试验中,FDA 指出,给予最大推荐剂量 Mounjaro 的患者的 HbA1c 比 Ozempic 降低 0.5%,比诺和诺德的 Tresiba(德谷胰岛素)降低 0.9%,比甘精胰岛素降低 1%。

Mounjaro 还在六项临床试验中被评估治疗肥胖的效果。礼来(Eli Lilly)最近报告了 SURMOUNT-1研究的结果,显示该药物帮助没有 2 型糖尿病的患者减轻了高达 22.5% 的体重。SURMOUNT-2、SURMOUNT-3 和 SURMOUNT-4 研究的结果将于 2023 年公布。

礼来(Eli Lilly)迄今为止尚未提交 Mounjaro 用于治疗肥胖的申请。分析师目前估计,到 2026 年,Mounjaro 的销售额可能达到 47 亿美元。同时,诺和诺德的 Ozempic 最初于 2017 年在美国获准用于治疗糖尿病,去年也以 Wegovy 的品牌名称获批用于慢性体重管理。

 

原始出处:

https://firstwordpharma.com/story/5571833

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    2022-12-17 bugit
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    2022-07-16 屋顶瞄爱赏月

    签到学习

    0

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    2022-05-17 赛华佗

    #糖尿病##tirzepatide#,这个是神药一类,有前途

    0

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