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梯瓦制药希望利用拉喹莫德治疗亨廷顿氏病
发布时间:2014/08/19

制药巨头梯瓦公司最近正在为其开发的新药拉喹莫德头痛不已。公司最近作出决定,将尝试利用这种药物治疗中枢神经疾病亨廷顿氏病,以拓展这种药物可能的适用范围。与梯瓦公司合作开发拉喹莫德的Active生物技术公司表示,双方计划下个月招募约400名亨廷顿氏病患者以评价拉喹莫德的对这种神经退行性疾病的治疗效果。据统计,目前在美国,亨廷顿氏病的发病率约为万分之一。

梯瓦公司一直将拉喹莫德作为是公司该领域目前多发性硬化症畅销药物Copaxone的继承者。Copaxone目前的年销售额达到了40亿美元并将于明年失去专利保护。但是拉喹莫德的研制并不是一帆风顺,今年一月和五月,欧洲人用药品管理委员会(Europe's Committee for Medicinal Products for Human Use,CHMP)两次否决了申请,原因是尽管拉喹莫德在缓解MS症状方面效果良好,但是却有着潜在致癌性和对孕妇过高的副作用。同时,尽管已经进行了两次临床三期研究,拉喹莫德对MS患者复发的效果并不尽如人意。目前梯瓦公司正在组织第三次相关临床研究。另外公司也已经完成了拉喹莫德治疗克罗恩氏病和狼疮的临床二期研究,预计公司将以Nerventra的商品名将其上市。

详细英文报道:

Teva Pharmaceutical ($TEVA) is rolling its troubled CNS drug laquinimod into a mid-stage study in Huntington's disease, looking to expand the potential of a treatment marked by clinical and regulatory setbacks.

Active Biotech, Teva's partner on the drug, said the company is setting out to test its oral medication on patients with Huntington's, an inherited neurodegenerative ailment that affects about one in every 10,000 Americans. Teva plans to kick off its study next month, enrolling about 400 patients to chart whether three doses of laquinimod can improve disease scores and motor function compared to placebo.

Meanwhile, the company is still toiling on laquinimod's primary indication: relapsing-remitting multiple sclerosis. The drug has long been tabbed as the successor to Teva's $4 billion-a-year MS treatment Copaxone, which comes off patent next year, but things haven't quite gone according to plan.

In May, Europe's Committee for Medicinal Products for Human Use (CHMP) declined to recommend laquinimod for approval, confirming a negative opinion handed down in January. In its first rejection, CHMP pointed to safety risks that cropped up in animal studies and weren't dispelled by later human trials, noting that exposure to laquinimod was tied to a higher occurrence of cancer and some dangers for pregnant women. On the efficacy side, the committee was satisfied with the treatment's ability to slow the progression of MS-related disability but unimpressed with its effect on relapses.

Laquinimod has endured two Phase III missteps on its way to regulatory uncertainty, repeatedly failing to significantly reduce relapse rates in MS patients. Teva is now in the midst of a third late-stage trial, dubbed CONCERTO, studying the treatment's effects on disability progression. Data from that study will likely support Teva's second go at EU approval,and the company has said it expects to win an FDA nod by 2018.

The drug, to be marketed as Nerventra, has also completed Phase II studies in lupus and Crohn's disease.