缓解慢性肾病进展还能降低心血管风险,拜耳新药Kerendia 或拥有巨大潜力

2021-08-09 K.K MedSci原创

Kerendia可以降低患有2型糖尿病(T2D)伴慢性肾病(CKD)成人患者估算的肾小球滤过率(eGFR)持续下降、终末期肾病、心血管疾病死亡、非致死性心肌梗死和因心力衰竭住院的风险。

近日,据国外生物网站Fierce Pharma 报道,当拜耳最畅销的眼药药物Eylea和血液稀释剂Xarelto失去专利时,它正打算推广一种 "肾脏药"——Kerendia。Kerendia(finerenone)非奈利酮是一种潜在first-in-class非甾体、选择性盐皮质激素受体拮抗剂(MRA),能减少盐皮质激素受体(MR)过度激活的有害影响。盐皮质激素受体过度激活是肾脏和心脏损害的主要驱动因素,它与Viatris公司的心脏药物依普利酮有着共同的作用机制。

上个月获批的Kerendia可以降低患有2型糖尿病(T2D)伴慢性肾病(CKD)成人患者估算的肾小球滤过率(eGFR)持续下降、终末期肾病、心血管疾病死亡、非致死性心肌梗死和因心力衰竭住院的风险。

 

finerenone作用机制(图片来源:researchgate.net)
 

在其批准中,FDA引用了拜耳的5600人的后期试验,即FIDELIO-DKD,FIDELIO-DKD研究是一项随机、双盲、安慰剂对照研究,共招募5734例患者,受试者按1:1随机分为2组,分别接受Kerendia和安慰剂治疗。时间-事件分析中评估的主要复合终点为肾衰竭、eGFR较基线下降40%以上,或因肾原因死亡发生人数。时间-事件分析中评估的关键次要复合终点为心血管原因死亡、非致死性心肌梗死、非致死性中风或因心衰住院发生人数。研究结果论文发表在2020年12月3日的《新英格兰》期刊上。

Finerenone 的主要结果的发生率始终低于安慰剂

George L. Bakris et al.Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.NEJM.DOI: 10.1056/NEJMoa2025845

2.6年随访结果显示,Kerendia组主要结局事件发生率为17.8%( 504/2833),而安慰剂组这一比例为21.1%(600/2841),(HR:0.82;95%CI, 0.73 ~ 0.93; P = 0.001)。关键次要结局事件发率分别为13.0%(finerenone组)和14.8%(安慰剂组) (HR:0.86;95% CI, 0.75 ~ 0.99;P = 0.03)。

拜耳公司的数据显示,美国约有40%的2型糖尿病患者最终会发展成慢性肾病,其中许多人面临着心血管疾病的高风险。Kerendia旨在阻止体内类固醇的产生,而类固醇的产生会降低人的心脏功能,并损害肾脏。

2015年,糖尿病肾病和肾小球肾炎CKD住院人数百分比分别为1.1%和0.8%,在中国糖尿病肾病取代肾小球肾炎,成为慢性肾脏病(CKD)住院患者的主流人群。中国CKD患者的多中心前瞻性队列研究提示,18.1%的CKD患者合并糖尿病。因此,糖尿病和CKD的并存已成为我国糖尿病研究和治疗领域面临的重大问题。拜耳也已在欧盟、中国以及全球多个国家提交Kerendia上市许可,这些申请目前正在审查中。

不过,阿斯利康的达格列净也被批准用于减少不同环境中的肾脏或心脏相关问题。阿斯利康的Farxiga(达格列净)是一种钠-葡萄糖共转运体2(SGLT2)抑制剂,已在美国获得批准,用于降低有进展风险的成人慢性肾病患者的估计肾小球滤过率持续下降、终末期肾病、心血管死亡和心衰住院的风险。但是达格列净比Kerendia更便宜,Kerendia的上市价格约为每天19美元。

拜耳制药公司首席执行官 Oelrich认为,不应该将Kerendia与达格列净进行价格比较,达格列净最初作为一种治疗糖尿病药物被批准并广泛使用,而Kerendia显然不是一种治疗糖尿病药物。Oelrich说,为了使其上市,拜耳正在与商业支付方合作以获得报销。此外,该公司服务的医生群体包括肾脏病医生、内分泌医生和初级保健医生。

在第二季度,拜耳制药部门的销售额按固定货币计算增长了16.2%,达到44.9亿欧元(53.2亿美元)。

其避孕药物组合去年在新冠期间严重受挫,按固定汇率计算,销售额增长了68%,达到2.93亿欧元。拜耳的眼科药物Eylea收益也回升了27%,达到7.11亿欧元。

由于业绩表现,拜耳预计今年制药方面将有6%的增长,高于之前预计的4%。就整个公司而言,第二季度的销售额提升了12.9%,达到108.5亿欧元。拜耳现在预计其全年收入可能达到约440亿欧元,高于之前的420亿~430亿欧元。

原文出处:

  1. https://www.fiercepharma.com/pharma/kidney-medicine-bayer-touts-kerendia-potential-as-pharma-swings-back-to-growth
  2. George L. Bakris et al.Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.NEJM.DOI: 10.1056/NEJMoa2025845

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    2021-12-21 洁巴子
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    2021-08-11 ying_wu
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    2021-08-09 乐乐369

    0

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    2021-08-09 xiaoyu12

    有意思

    0

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