梯瓦公司治疗多发性硬化症（multiple sclerosis）长效药物Copaxone曾经每年为公司带来40亿美元的收入，然而这棵"摇钱树"将于明年失去专利保护。梯瓦公司也开始早早布局寻找Copaxone的替代者。而Laquinimod就是梯瓦公司的又一个希望。然而最近欧洲的人用药品管理委员会（Committee for Medicinal Products for Human Use, CHMP）却再次否决了Laquinimod的上市申请。此前CHMP以这种药物安全性问题为由在今年一月份要求梯瓦补充更多的研究材料。据了解，CHMP主要是担心其致癌风险以及对孕妇有较大危害。不过管理人员也承认其疗效令人满意。不过，梯瓦公司仍然对其新药充满信心，并计划提交更多数据以说服欧洲的医药管理部门。同时公司计划于2018年获得美国医药部门的上市批准。

原文：Teva's ($TEVA) $4-billion-a-year multiple sclerosis treatment Copaxone is slated to lose patent protection next year, and the Israeli drugmaker is struggling to move the needle on its planned replacement, enduring another rejection from European reviewers.

The continent's Committee for Medicinal Products for Human Use (CHMP) declined to recommend Teva's laquinimod for approval, confirming a negative opinion handed down in January. The drug, which Teva hopes to market as Nerventra, is an oral treatment for relapsing-remitting MS, developed alongside partner Active Biotech.

Despite the second rejection, Teva said it has no plans to give up on the treatment, plotting to review CHMP's feedback and retool for another application.

"We are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to multiple sclerosis patients in the EU," Teva R&D boss Michael Hayden said in a statement.

In its first rejection of the drug, CHMP highlighted safety risks that cropped up in animal studies and weren't quelled by later human trials, pointing out that exposure to laquinimod was tied to a higher occurrence of cancers 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 trouble, 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 U.S. approval by 2018.