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再下一城!诺华牛皮癣药物临床三期数据击败强生Stelara

  1. secukinumab
  2. Stelara
  3. 强生
  4. 牛皮癣
  5. 诺华

来源:生物谷 2014-12-15 10:28

牛皮癣是一种常见疾病,但是这种疾病却是炎症类疾病的一个代表。由于患病人数众多,再加上这种疾病很容易复发。因而,牛皮癣药物市场已经成为一个各大生物医药巨头都想分上一块的大蛋糕。

2014年12月15日讯 /生物谷BIOON/ --牛皮癣是一种常见疾病,但是这种疾病却是炎症类疾病的一个代表。由于患病人数众多,再加上这种疾病很容易复发。因而,牛皮癣药物市场已经成为一个各大生物医药巨头都想分上一块的大蛋糕。

最近诺华公司在这一领域可谓是春风得意。先是几年早些时候的临床对比研究中,诺华公司的secukinumab击败了安进公司的牛皮癣畅销药物Enbrel,而后者为安进公司一年进账达90亿美元之多!最近,公司又宣布,在与强生公司的Stelara进行的对比研究中,secukinumab又毫无悬念的胜出。这一结果也为诺华公司的secukinumab最终登陆美国和欧洲市场增加了又一枚筹码。

在这项有679名牛皮癣患者参加的临床三期对比研究中,接受secukinumab治疗16周的患者牛皮癣改善情况达到了90%之多,达到了实验预期的首要终点。其次,接受secukinumab治疗四周的患者,牛皮癣症状改善程度达到75%以上。Secukinumab主要是通过阻断人体中一种名为IL-17的炎症因子而达到治疗牛皮癣的目的。

早在今年十月份,美国FDA下属的专家委员会就已经讨论通过并建议批准这一药物上市。分析人士预计,这一药物最快将于明年一月份登陆美国市场。欧洲医药管理部门也在今年十一月份做出了类似决定。如果一切顺利的话,诺华公司的secukinumab将成为首个登陆欧洲市场的IL-17阻断剂药物。

目前牛皮癣患者接受治疗时一般都会选择肿瘤坏死因子(TNF)抑制剂类药物,如Enbrel和艾伯维公司的Humira。

尽管该药临床表现突出,不过这并不能表示诺华公司将很快独霸整个牛皮癣药物市场。因为,紧随其后,安进公司和阿斯利康公司合作的抗IL-17药物brodalumab、礼来公司的ixekizumab以及默沙东和强生公司的抗IL-23药物guselkumab也纷纷进入临床三期研究。这些药物都会对诺华公司构成潜在挑战。(生物谷Bioon.com)

详细英文报道:

Novartis' ($NVS) new anti-inflammatory treatment cleared up psoriasis better than Johnson & Johnson's ($JNJ) Stelara in a Phase III trial, a second head-to-head victory for the injectable drug as it nears U.S. and European approvals.

In a 679-patient study, Novartis' secukinumab met its primary goal of reducing psoriasis symptoms by at least 90% at 16 weeks, the company said, demonstrating superiority to J&J's treatment. The antibody also met its secondary endpoint of improving the signs of psoriasis by at least 75% after four weeks, according to Novartis.

Stelara, which brought in $1.5 billion for J&J last year, is the latest victim of Novartis' ambitious clinical program for secukinumab. The treatment, which blocks an inflammation-related protein called interleukin-17, beat out Amgen's ($AMGN) roughly $9-billion-a-year Enbrel in a Phase III study earlier this year.

The treatment, to be marketed as Cosentyx, is on its way toward a likely FDAapproval, winning a unanimous recommendation from an agency panel in October and expecting final word in January. The European Medicines Agency has also signed off on secukinumab's promise, handing down a recommendation for approval last month and setting the stage for a 2015 continental launch. If all goes according to plan, Novartis' injection will be the first IL-17 blocker to hit the market, leading a pack of new treatments that could improve the standard of care for psoriasis, psoriatic arthritis and other inflammatory diseases.

As it stands, the most common option for psoriasis sufferers is injected therapies that inhibit tumor necrosis factor (TNF), including Enbrel and AbbVie's ($ABBV) top-selling Humira. But Novartis believes its contender can disrupt the market, pointing to a National Psoriasis Foundation survey in which 52% of patients surveyed said they were dissatisfied with their disease management.

"We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors," Novartis Head of Development Vasant Narasimhan said in a statement. "Patients need more effective treatment options for psoriasis and these impressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx."

But while Novartis will likely be first to the IL-17 market, it's soon to be joined by a slew of other anti-inflammatory biologics targeting the same multibillion-dollar space. Behind secukinumab is Amgen and AstraZeneca's ($AZN) brodalumab, a similar treatment that beat Stelara in a Phase III study of its own. Meanwhile, Eli Lilly ($LLY) is in the midst of Phase III with the IL-17-blocking ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's IL-23 inhibitor guselkumab, which is set to enter Phase III this quarter.

 

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