骨质疏松症新药Evenity(romosozumab)获多国批准上市,中国临床试验也已开展

2020-06-05 MedSci MedSci

2019年1月,安进(Amgen)和优时比(UCB)宣布,其联合开发的用于治疗高骨折风险的骨质疏松症新药Evenity(romosozumab),已获得日本厚生劳动省颁发的上市许可,用于降低骨折高危男

2019年1月,安进(Amgen)和优时比(UCB)宣布,其联合开发的用于治疗高骨折风险的骨质疏松症新药Evenity(romosozumab),已获得日本厚生劳动省颁发的上市许可,用于降低骨折高危男性和绝经后女性骨质疏松症患者的骨折风险并增加骨密度。值得一提的是,这是Evenity在全球获得的首个上市许可。目前FDA和EMA(欧洲药品管理局)也正在审核Evenity的上市申请。romosozumab获得美国FDA骨、生殖和泌尿外科药物咨询委员会(BAUDAC)的强力支持(18:1)。美国FDA正式批准romosozumab上市,用于治疗绝经后女性伴高骨折风险的骨质疏松症,商品名为Evenity®。Romosozumab也成为全球首款获批上市的抗sclerostin单克隆抗体药物。

2019年12月,中国国家药监局药品审评中心(CDE)官网显示,安进/优时比抗硬骨素蛋白(sclerostin)的单抗新药Romosozumab注射液的临床试验申请获得默示许可,具体适应症为:治疗高骨折风险的绝经后女性的骨质疏松。

骨质疏松症是一种由骨骼密度和质量下降引起的疾病。骨质疏松症会让人的骨骼变弱变脆,很大程度增加了骨折的风险。骨质的丢失是消无声息的渐进过程,因此在首次骨折前通常无任何症状。据统计,在全球范围内,有三分之一的女性和五分之一的男性面临骨质疏松性骨折的风险。骨质疏松症的治疗和维持,特别是在骨折后的情况下,仍有巨大的进步空间。

骨质疏松症是一种由骨骼密度和质量下降引起的疾病。人体的骨头是不断变化的活组织。名为“骨重建”的过程为:破骨细胞溶解骨基质,而成骨细胞则能积累骨基质。对于骨质疏松症患者来说,骨质溶解流失超过了新骨生长的速度,导致骨骼变得多孔脆弱,进而发生骨折的风险大大增加。

据统计,在全球范围内,有三分之一的女性和五分之一的男性面临骨质疏松性骨折的风险。而在美国50岁以上的女性中,骨折发生率为二分之一,而且经历初次骨折后再次骨折发生的可能性会增加两倍。骨质疏松症的治疗和维持,特别是在骨折后的情况下,仍有巨大的进步空间。预计有五分之四的患者在骨折后仍未得到诊断以及治疗。如果没有适当的护理或有效的干预,他们面对着痛苦的乃至致残性的骨折风险。

Romosozumab是安进与优时比联合开发的抗硬骨素蛋白的单抗药物,可抑制骨硬化蛋白的活性,从而同时加速骨形成并减少骨吸收,开发用于男性、女性骨质疏松症治疗。骨硬化蛋白是一种分泌性糖蛋白。体内研究证明,骨硬化蛋白特异性地表达于骨细胞中,并抑制成骨细胞的骨形成。通过拮抗骨硬化蛋白可以缓解骨质疏松的症状,这为临床治疗骨质疏松等疾病提供了新思路与新方法。

FDA的批准是基于romosozumab三项关键3期试验(FRAME和ARCH)的研究数据。

FRAME(NCT01575834)是一项多中心、国际性、随机、双盲、安慰剂对照、平行组研究试验,在7180名绝经后骨质疏松症女性患者中开展。结果表明,与对照组相比,接受治疗12个月后,Evenity能够将新椎体骨折风险降低73%(p<0.001);接受治疗24个月后,Evenity能够将新椎体骨折风险降低75%(p<0.001)。并且能使患者骨密度(BMD)显著增加,腰椎(12.7%)、髋关节(5.8%)、股骨颈(5.2%)。组织形态学评估结果显示,接受romosozumab治疗的患者在新骨形成和骨再吸收减少的同时,也能够增加骨量,骨小梁和皮层厚度。

ARCH(NCT01631214)是一项随机、双盲、阿仑膦酸钠(alendronate)对照试验,在4093名有既往骨折史,骨折风险高,绝经后的骨质疏松症患者中开展。在12个月的Evenity治疗(210mg)后,再进行至少12个月的阿仑膦酸钠(70mg)治疗。结果表明,与单独使用阿仑膦酸钠2年组相比,使用romosozumab治疗1年后再使用阿仑膦酸钠继续治疗1年可使新发椎骨骨折的风险降低48%(p<0.001)。并且能使患者骨密度(BMD)显著增加,腰椎(8.1%)、髋关节(3.8%)、股骨颈(3.8%)。

BRIDGE是一项随机、双盲、安慰剂对照试验,在245名年龄在55-90岁之间,患有骨质疏松症和有脆性骨折史(不包括髋关节骨折)或椎体骨折史的男性患者中进行。为期12个月的BRIDGE试验旨在评估,与安慰剂相比,Evenity对增加腰椎骨密度以及对股骨颈和全髋关节骨密度的有效性。结果显示,与安慰剂组相比,romosozumab治疗12个月使骨质疏松症男性患者的脊柱和髋部骨密度显著增加

不良反应:最常见的不良事件包括关节痛,头痛,肌肉痉挛,外围水肿,乏力,颈部疼痛,失眠,皮肤感觉异常等。

黑框警告提示该药可能会增加心肌梗死(心脏病发作)、中风和心血管死亡的风险。该药不应在过去一年内心脏病发作或中风的患者中使用。在其他心血管风险因素的患者中,应权衡治疗益处是否大于风险。如果患者在治疗过程中发生心脏病发作或中风,应停止使用romosozumab治疗。

目前,Evenity还在韩国被批准用于骨折高危男性和绝经后女性骨质疏松症患者,在加拿大被批准治疗骨折高危绝经后女性治疗骨质疏松症。

事实上,romosozumab在美国的审评之路经历了约两年9个月。2016年7月,基于基于FRAME临床数据,安进和优时比首次向FDA递交了romosozumab的上市申请。一年后(2017年7月),FDA发出完全回复函要求补充递交最新临床试验数据。2018年7月,安进和优时比第2次向FDA递交了romosozumab上市申请。

此外,FDA批准Evenity的标签里将其批准仅限于高危骨折的绝经后妇女,并建议医生限制使用至12个月。同时伴有一个黑框警告,提示该药可能会增加心肌梗死(心脏病发作)、中风和心血管死亡的风险。FDA还要求开展上市后研究,评估Evenity在绝经后女性骨质疏松症患者中的心血管安全性,包括一项为期5年的观察性可行性研究,随后可能进行一项比较安全性研究。

  安进骨质疏松创新药romosozumab中国获批临床

Romosozumab的心血管风险这个“硬伤”在ARCH研究中展露无疑。与阿仑膦酸组对照,Evenity组的心血管风险增加了30%——比较心血管复合终点事件发生率,Evenity组2.5% vs阿仑膦酸1.9%。

因此,尽管在美国的审评之路曲折但好在终获批,欧盟则直接将romosozumab 拒之门外。2019年6月27日,安进与优时比宣布双方接到通知,欧洲药品管理局(EMA)人用医药产品委员会(CHMP)对romosozumab治疗严重骨质疏松症的上市申请给予了“不建议批准”的意见。拒绝批准的理由主要是担心接受romosozumab的患者出现严重心脏或循环系统(如心脏病发作或中风)的风险增加。

其他主要anti-sclerostin抗体研发进展

BPS-804(setrusumab)用于治疗成骨不全症(OI)。OI是一种罕见的遗传性疾病,其特征是骨量低下、骨骼脆性增加和反复骨折,主要是由多种致病基因突变导致的。BPS-804是一种靶向于硬化蛋白的全人源IgG2型单克隆抗体,可抑制硬化蛋白(抑制骨形成细胞活性的蛋白)的功能,用于成骨不全症的治疗,目前处于临床II期研究阶段。

Blosozumab是由礼来研发用于治疗骨质疏松症的创新生物药。今年3月28日,创胜集团 (Transcenta Holding) 正式宣布其全资子公司奕安济世生物药业与礼来签署合作协议,获得了礼来在骨病治疗领域开展一系列创新生物药产品线的独家开发授权,其中包括了处于临床II期的blosozumab,这也使其有望明年在中国进入临床试验。

SHR-1222是唯一一款由国内企业(江苏恒瑞医药股份有限公司及子公司上海恒瑞医药有限公司、苏州盛迪亚生物医药有限公司)研发的SO靶点生物制品1类新药,目前正在开展I期临床试验。

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    2020-06-05 lifefamily@163

    #骨质疏松症#国内重视程度不够,大部分人没有充分治疗

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    2020-10-16 snf701207
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    2020-07-29 jiyangfei
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    2020-06-07 Eleven17

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