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Dyax公司遗传性血管水肿新药DX-2930收获FDA突破性药物资格

2015-07-09 佚名 生物谷

生物制药公司Dyax研发的一款治疗遗传性血管水肿(HAE)的药物DX-2930近日收获FDA的突破性疗法认定(BTD)。DX-2930是一种全人源化单克隆抗体,靶向抑制血浆激肽释放酶(pKal),目前正开发作为一种皮下注射药物,用于预防HAE的发作。 突破性疗法认定(BTD)旨在加速开发及审查针对严重或危及生命的疾病具有治疗潜力的新药。获得BTD的药物,在研发时能得到包括FDA高层官员在内的更加

生物制药公司Dyax研发的一款治疗遗传性血管水肿(HAE)的药物DX-2930近日收获FDA的突破性疗法认定(BTD)。DX-2930是一种全人源化单克隆抗体,靶向抑制血浆激肽释放酶(pKal),目前正开发作为一种皮下注射药物,用于预防HAE的发作。

突破性疗法认定(BTD)旨在加速开发及审查针对严重或危及生命的疾病具有治疗潜力的新药。获得BTD的药物,在研发时能得到包括FDA高层官员在内的更加密切的指导,保障在最短时间内为患者提供新的治疗选择。

FDA授予DX-2930突破性疗法认定,是基于在遗传性血管水肿(HAE)患者中开展的一项Ib期临床试验的积极数据。数据显示,与安慰剂相比,DX-2930显著降低了患者每周HAE发作的平均次数。此外,该研究也达到了安全性、耐受性、多次皮下注射DX-2930的药代动力学等所有目标。Dyax已计划在今年晚些时候启动一项II期临床研究。

事实上,Dyax公司早在2009年就推出了一款皮下注射药物Kalbitor,该药是继Berinert(一种来源于血浆的C1酯酶抑制剂)之后FDA批准的第2种HAE治疗药物,也是首个治疗急性HAE发作的皮下注射药物。去年4月,FDA进一步批准扩大Kalbitor的适用人群,用于12岁及以上HAE患者。Kalbitor上市之后,竞争对手Shire和Salix也推出了各自的HAE治疗产品。据Dyax公布的数据,Kalbitor在去年的销售额为6500万美元。

除了HAE,Dyax目前也正在调查血浆激肽释放酶(pKal)相关的疾病,将其专有的技术用于糖尿病性黄斑水肿、炎症性肠病、类风湿性关节炎及其他疾病的潜在治疗。DX-2930是一种新型的全人源化单克隆抗体,靶向抑制pKal。不受控的pKal活动可导致缓激肽(bradykinin)的过度生成,这是一种血管扩张剂,可引发HAE相关的局部肿胀、炎症及疼痛。

遗传性血管水肿(HAE)是一种罕见的、遗传性、急性炎症性疾病,致病基因为C1酯酶抑制剂(C1-INH)基因,该基因突变导致患者血清中C1酯酶抑制因子减少或功能缺陷,不足以抑制缓激肽生成级联反应,而使体内大量缓激肽生成引发血管通透性增高、血浆外渗,进而引起局部组织水肿。该病临床表现为反复发作的皮肤和黏膜下水肿,可累及四肢、颜面、外生殖器、呼吸道或消化道黏膜。患者常因肠道水肿引发腹部剧烈疼痛及其他消化道症状。而呼吸道黏膜水肿可导致憋气、呼吸困难,严重者可出现窒息甚至死亡。

原始出处:

Damian Garde.Dyax gets an FDA 'breakthrough' tag for its rare disease drug.FierceBiotech, July 7, 2015.

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    2015-07-11 cmn

    看看

    0

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    2015-07-11 小华子
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    2015-07-09 huaxipanxing

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