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安进心脏病药物ivabradine获FDA首肯登陆美国市场

来源:生物谷 2015-04-16 16:17

2015年4月16日讯 /生物谷BIOON/ --安进公司最近宣布,公司开发的心脏病药物ivabradine已经获得了FDA的批准,并将在未来几个月内以Corlanor的商品名进入临床。这也是目前世界上首个以降低心脏病患者心跳速率和住院率的新型心脏病药物。

Ivabradine于去年秋天获得了FDA的专家委员会审核通过,此次FDA对该药物作出最终决定的日期也早于原定计划。这一结论主要是在公司提交了一项有6500名心脏病患者参与的临床研究基础上作出的。在这项研究中,相对于安慰剂组,ivabradine成功延迟了患者因心脏病病发而首次入院的时间。

不过,尽管ivabradine获得了美国人的认同,但是这种药物在欧洲市场上却引起了不大不小的争论。因为去年安进公司在欧洲进行了一项为期三个月的关于冠状动脉疾病临床研究中,虽然成功将患者每分钟心跳次数降低了10次,但在心脏病死亡率方面未能与对照组产生明显区别。

Corlanor是安进公司花费5000万美元从Servier公司获得的,按照协议规定,安进公司将获得这种药物在美国市场的销售权利。安进公司心血管疾病部门主管Dr. Norman Stockbridge表示,目前心脏病已经成为威胁成年人健康的最大元凶之一,corlanor是目前首个获批的能够降低心跳速率的新型药物,这对改善心脏病人的生存状况有很重要的帮助。

心血管疾病领域一直是安进公司研发的重点。而在近年来竞争最为火爆的PCSK9研究领域,安进公司凭借evolocumab与赛诺菲等生物医药巨头一直保持着领先优势。(生物谷Bioon.com)

详细英文报道:

Amgen has won an FDA approval for the heart drug ivabradine, which will hit the market as Corlanor. This is the first approval for a new class of drug aimed at preventing hospitalization for a deteriorating heart, slowing down heart rates, and it's also the first in a badly needed string of approvals Amgen is counting on to finally quiet critics of its pricey R&D operations.

Amgen ($AMGN) won the approval a little ahead of the FDA's regular schedule after gaining priority review status last fall. The FDA OK'd the drug--which has proved to be controversial in Europe--after Amgen offered data on more than 6,500 patients demonstrating that it reduced the time to first occurrence of hospitalization for worsening heart failure compared to placebo.

The drug was originally in-licensed back in 2013 from Servier, which was already selling it in Europe. Amgen paid $50 million upfront to gain U.S. rights while outlicensing European rights to omecamtiv mecarbil. The drug failed a three-month European study last fall--dubbed SIGNIFY, which studied a population of patients with chronic stable coronary artery disease without heart failure--lowering heart rates by 10 beats per minute on average but failing to make a distinct improvement over a placebo in reducing cardiac deaths.

As Forbes cardio contributor Larry Husten noted last fall, the EMA's Pharmacovigilance Risk Assessment Committee reviewed the drug and concluded that patients should be monitored for atrial fibrillation, the drug should not be prescribed with verapamil or diltiazem and "concluded that ivabradine 'should only be started if the patient's resting heart rate is at least 70 beats per minute.' The drug should only be used for the symptomatic relief of angina because it 'has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death.'"

"Heart failure is a leading cause of death and disability in adults," said Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research. "Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class."

Amgen's blockbuster bid for the PCSK9 drug evolocumab, in a hectic race with a rival program from Sanofi ($SNY) and Regeneron ($REGN), remains the Big Biotech's primary new drug hopeful. Talimogene laherparepvec is up for a possible approval this fall for skin cancer. And an application for the late-stage anti-inflammatory brodalumab, partnered with AstraZeneca ($AZN), is also in the works for later this year as the company continues to push at expanding its market for Kyprolis.

Hedge fund manager Daniel Loeb and Bernstein analyst Geoffrey Porges have been leading the call for the company to split, with Porges harshly criticizing Amgen for what he considers a hodgepodge of therapies in the late-stage pipeline. Amgen, meanwhile, has been slashing deep into its R&D organization in an effort to trim expenses, most recently shuttering its operations at Onyx and cutting about 300 staffers involved in a variety of functions.

 

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