原标题:老年痴呆有治了?世界首款阿兹海默药有望量产
针对阿茨海默症(俗称老年痴呆症)的药物研发一直是全球医药界的一大难题。目前,全球约有5000万人饱受阿兹海默症的困扰,而且这一群体的数量预计还将继续增长。但是,阿茨海默症治疗药物的研发进展却一直相当缓慢。
当地时间10月22日,美国百健公司(Biogen)宣布,世界首款可治疗阿兹海默症状的药物aducanumab已经通过临床测验,正待FDA批准,有望量产。
今年三月aducanumab药物第三阶段的临床研究受阻,未能达到预期目标。但是周二,Biogen宣布了新的研究数据,称研究取得突破进展。
The data showed that patients who received aducanumab experienced significant benefits on measures of cognition and function, including memory, orientation and language, according to Biogen。
Biogen称临床测验数据表明,aducanumab药物对阿兹海默症患者在认知和各项功能指标上(包括记忆力,方向和语言)方面均奏效。
The company Biogen said it will file an application with the FDA in early 2020 and will continue discussions with regulatory authorities in Europe and Japan。
Biogen公司称将在2020初年向美国食药监局FDA报批,也会和欧洲和日本的监管机构沟通。
Via CNN
是否获批仍存疑问。
“I really hope these new analyses pan out,” said Dr。 Richard Isaacson, director of the Alzheimer‘s Prevention Clinic at Weill Cornell Medicine in New York, who had patients in the original clinical studies。
“我真的希望这些新的研究能取得成功,威尔•康奈尔医学院老年痴呆症预防诊所主任Richard Isaacson博士说,他曾给患者进行过最初的临床研究。
“I‘m not surprised that a reanalysis of the data showed something positive,” he said, adding, “I do believe that there are going to be probably continued regulatory hurdles。” Additionally, the drug could be extremely expensive, Isaacson said。
他说:“数据分析的结果显示这个药物有积极的治疗效果,我并不感到惊讶,”他补充说,“但我认为在监管审批方面可能还会遇到一些瓶颈。”此外,他认为这种药物可能非常昂贵。
“But is that going to be enough for the FDA to approve this from a regulatory perspective? Would payers reimburse it? I don‘t know, but I hope so,” he said。
“但是从监管角度上说,这是否足以使FDA批准?可以买得起吗?我不知道,但我希望如此。”
Via CNN
阿兹海默症是美国第六大死亡原因。目前,美国约有580万人患有阿兹海默症,到2050年,这一数字预计将增至近1400万人。
While Alzheimer‘s effects about 50 million people globally, there are no approved therapies to slow or reverse the effects of the disease。
尽管阿兹海默症在全球范围内影响约5000万人,但尚无已经获批的,可以减缓或逆转该疾病的药物。
Via CNN
网友表示希望早日量产: