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诺和诺德考虑调整Tresiba监管策略,或对长效胰岛素市场产生重大影响

  1. Tresiba
  2. Xultophy
  3. 诺和诺德
  4. 长效胰岛素

来源:生物谷 2014-11-03 09:08

Tresiba获欧盟批准,却被FDA拒绝。目前,长效胰岛素市场,赛诺菲已提交Toujeo上市申请,礼来2015年初提交peglispro申请,Tresiba何时上市尚无时间表。

2014年10月30日讯 /生物谷BIOON/ --诺和诺德长效胰岛素产品Tresiba早在2013年1月就获得了欧盟的批准,但该药在美国监管方面却遭到了FDA的拒绝。今年8月,诺和诺德宣称,预后研究进度超过预期,预计今年底开展中期分析,2015年上半年再次提交上市申请。但近日,诺和诺德在谈及Tresiba上市时间表时已变得相当谨慎,该公司表示正在考虑对Tresiba的监管策略进行调整,其最终决定或对长效胰岛素市场产生重大影响。

去年2月,FDA因一些令人不安的心血管风险,拒绝批准Tresiba,并要求诺和诺德开展费钱费时的心血管预后研究证明Tresiba的安全性,并告知在此之前不能重新提交Tresiba的上市申请。FDA此举导致Tresiba最早可能到2017年才能登陆美国市场。不过,今年8月,诺和诺德宣布,Tresiba预后研究进度比原计划提前,计划于今年年底开展中期分析,可能在2015年上半年再次向FDA提交Tresiba上市申请,并最终会在2016年将Tresiba推向美国市场。

但周四,在与分析师的电话会议上,诺和诺德的言词却相当谨慎。该公司表示,目前尚未决定是否向FDA提交中期数据或者等待DEVOTE研究最终完成。诺和诺德首席科学官Mads Krogsgaard在电话会议上称,将在2015年年中看了中期数据之后,再决定是否要直奔FDA或等待最终结果。然而,该项研究,从现在算起可能需要长达3年的时间才能完成。

Mads Krogsgaard同时表示,公司对DEVOTE研究及中期分析的信心丝毫不变,这只是监管策略上的一个调整,与最终研究结果相比,中期分析结果存在较高的不确定性,可能导致中期结果不支持但最终结果却支持再次提交Tresiba监管申请的情况发生。

诺和诺德的最终决定可能会对长效胰岛素市场产生重大影响,因为Tresiba很快将面临竞争,赛诺菲已向FDA提交了长效胰岛素Toujeo(U300)的上市申请,该药在临床试验中疗效超越来得时(Lantus)且低血糖风险更低,开发定位为来得时的替代品。另一方面,礼来已计划在2015年第一季度向FDA和欧盟提交长效胰岛素peglispro的上市申请。

业界认为,诺和诺德长效胰岛素产品Tresiba最大的潜力可能存在于糖尿病鸡尾酒Xultophy中,该药是首个长效胰岛素和GLP-1受体激动剂的复方药,由Tresiba和Victoza(liraglutide,利拉鲁肽)组成。在临床试验中,Xultophy不仅显著改善了血糖水平,同时还提供了显著的减肥作用。业界预测,Xultophy将成诺德又一枚重磅产品,如获FDA批准,前途更是不可估量,但Tresiba何时获FDA批准尚无时间表,因此难以确定Xeltophy的真正潜力。(生物谷Bioon.com)

相关链接:降糖减肥两不误——诺和诺德糖尿病鸡尾酒Xultophy获欧盟批准

英文原文:Novo Nordisk walks back some U.S. optimism for its next-gen insulin

Novo Nordisk ($NVO) is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.

Last year, the FDA rejected Tresiba over some troubling safety signals, demanding a costly cardiovascular outcomes study and effectively delaying Novo's plans to launch the product until 2017, at the earliest. However, in August, Novo announced that its outcomes trial was progressing ahead of schedule. The company was on track to conduct an interim analysis by the end of this year, potentially allowing it to submit data to the FDA in the first half of 2015 and finally launch the product in the U.S. in 2016.

But on a conference call with analysts on Thursday, Novo was considerably less bullish. The company now says it hasn't yet decided whether to submit that interim data to U.S. regulators or hold out for the full study, meaning that 2017-or-later timeline is still in play. Novo will get its first peek at interim results in the middle of next year, Chief Science Officer Mads Krogsgaard Thomsen said on the call, and only then will it decide whether to head straight back to the FDA or wait out its multi-year DEVOTE study.

"Our confidence in the DEVOTE and the interim analysis is completely unabated and unchanged," Thomsen said, according to Reuters. "It is just a change in the strategy."

Novo's final decision will likely have major implications on the market for long-acting insulins, as Tresiba, already approved in Europe, is soon to face competition. Sanofi ($SNY) has submitted Toujeo, a longer-acting successor to top-selling insulin Lantus, for FDA approval, and Eli Lilly ($LLY) expects to file its rival peglispro for approval in the first quarter of next year.

The biggest potential for Novo's new insulin may be its role in an investigational combo therapy. Xultophy, which combines Tresiba with the blockbuster GLP-1 drug Victoza, came through with stellar Phase III results earlier this year, improving Type 2 diabetics' blood sugar without the weight gain associated with long-acting insulins. However, because the U.S. requires any combo product to be made up of two or more approved treatments, any further delay to Tresiba will only prolong Novo's ambitions.

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