赛诺菲/Regeneron开发PCSK9新药alirocumab临床试验击败Zetia

赛诺菲/Regeneron开发PCSK9新药alirocumab临床试验击败Zetia

                               
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发布日期：2014-11-20  来源：生物谷

3 \: q+ W4 D2 |8 d赛诺菲公司和Regeneron公司联合开发的用于降低有害胆固醇的药物alirocumab最近又取得了新进展。公司表示在治疗他汀类药物不耐患者的临床研究中，alirocumab表现优异，击败了默沙东的Zetia。

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赛诺菲公司和Regeneron公司联合开发的用于降低有害胆固醇的药物alirocumab最近又取得了新进展。公司表示在治疗他汀类药物不耐患者的临床研究中，alirocumab表现优异，击败了默沙东的Zetia。这也使得alirocumab有望成为新型心脏病药物进入市场。

此次赛诺菲公司和Regeneron公司进行的临床三期研究中共招募了360名患者，实验数据显示，alirocumab治疗组的LDL胆固醇水平降低了45%，同时有42%的患者LDL胆固醇水平降低至标准水平；而Zetia治疗组中这两个数字分别仅为14.6%和4%。这一结果也大大增加了alirocumab获得FDA批准的可能性。赛诺菲公司和Regeneron公司的研究人员已经将这一研究结果在美国心脏病学会上公布。而今年早些时候，安进公司开发的同类药物evolocumab也取得了出色的研究成果。这两种药物都是一种能够阻断PCSK9蛋白的抗体类药物。通过阻断PCSK9,药物能够帮助机体清除血液中的LDL胆固醇。而分析人士预计这一市场规模大约在100亿美元左右。本周早些时候，默沙东公司Zetia研究数据证明了降低LDL胆固醇含量能够帮助心脏病患者延长生存期，降低心脏病发病概率。这一结果无疑将极大刺激PCSK9药物市场的扩大。

不过，现在还不能确定谁将成为这一市场的最大赢家，因为安进公司、辉瑞公司也在这一领域有着类似产品。且它们的研究数据表现差相仿佛。因此分析人士预测，PCSK9市场不太可能出现一家独大的场景，而更可能是三足鼎立的局面。

详细英文报道：

Sanofi ($SNY) and Regeneron's ($REGN) alirocumab resoundingly beat out Merck's Zetia in helping statin-intolerant patients lower their bad cholesterol in a study, data that bolster the case for a new class of highly anticipated cardio drugs.

As Reuters reports, among the 360 patients in a Phase III study, those in the alirocumab arm reported a 45% LDL cholesterol reduction compared to just 14.6% for subjects taking Zetia. Furthermore, Sanofi and Regeneron's drug helped 42% of patients get lower their LDL to target levels while only 4% hit the mark in the Zetia group.

The results, presented at the American Heart Association congress in Chicago, mirror a similar victory for Amgen's ($AMGN) competing evolocumab, which roughly halved bad cholesterol in statin-intolerant patients in a late-stage study disclosed earlier this year. Both treatments are antibodies designed to block the protein PCSK9, thereby helping the body clear LDL cholesterol from the blood, and analysts expect the market for such therapies to reach above $10 billion a year. Their broad success in patients who can't handle tried and cheap statins affirms what many figure will be a natural first population for the injectables once they hit the market.

And, thanks to Zetia, the approval and eventual adoption of PCSK9 blockers looks all the more likely. In results from a nearly decade-long study unveiled Monday, Merck's drug demonstrated a real, if modest, improvement in rates of heart attack, stroke and other cardiac events. That supports the premise that cutting cholesterol can extend lives, a hypothesis at the heart of the case for PCSK9 inhibition.

However, just which company will be first to test whether payers and physicians are on board remains to be seen.

Amgen, long the leader in a race that also includes Pfizer ($PFE), is expecting to win FDA approval for evolocumab no later than Aug. 27. That would have given it months of market exclusivity, but, over the summer, Sanofi and Regeneron paid $67.5 million for an FDA voucher that will cut alirocumab's review time down from 10 months to 6 months. Assuming the pair files its drug by year's end as planned, alirocumab will likely be up for approval at the same time if not before Amgen's contender. Further complicating matters, Amgen last month sued the makers of alirocumab, contending that the drug infringes its patents and seeking to block its eventual launch.

Analysts see few notable differences in efficacy between the leading PCSK9 contenders, figuring each will bring in peak sales of around $3 billion.

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不错的资料，楼主辛苦