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首页 » 诺华 » 诺华公司抗炎症药物secukinumab治疗银屑性关节炎取得重大突破

诺华公司抗炎症药物secukinumab治疗银屑性关节炎取得重大突破

来源:生物谷 2014-09-26 11:51

2014年9月26日讯 /生物谷BIOON/ --制药巨头诺华公司最近宣布,公司开发的新一代抗炎症药物secukinumab在日前治疗银屑性关节炎的两项临床三期研究中取得了突破性进展,这也为这种药物的最终上市再添筹码。

Secukinumab是一种注射用抗体类药物,这种药物能够阻断白介素17A的作用,而白介素17A在炎症过程中起到了相当重要的作用。

诺华公司此次进行的这两项临床三期研究共有超过1000名患者参加,临床结果显示,secukinumab达到了研究人员预计的首要终点和次要终点,相比于安慰剂组能够明显抑制银屑性关节炎的进程,防止关节损伤并保持皮肤清洁。同时诺华公司还表示在之前的研究中,研究人员已经证明了这种药物的安全性也令人满意。

诺华公司预计将于明年正式向FDA和欧盟医药管理部门提交上市请求,如无意外,secukinumab将于2015年年初正式进入市场销售。

一直以来,诺华公司都坚信其抗体技术能够取代现有标准的抗TNF疗法,如Enbrel和Humira。而后者的疗效经常会随着时间的推移而受到削弱。也正是由于这个原因,目前的银屑性关节炎药物市场上继续出现一种新的疗法,而诺华公司则希望通过抓住这一机遇在这一市场内一展所长。

不过,诺华公司并不一定会成为笑到最后的人,因为越来越多的制药公司也都在那里摩拳擦掌。本周,Celgene公司的抗TNF疗法药物Otezla已经获准上市。此外,安进、阿斯利康公司合作开发的IL-17A抑制剂药物brodalumab此前也收获了良好的临床三期研究。同时强生等公司也在这一领域有着自己的代表作。因此,究竟谁会成为笑到最后的赢家,还需要时间来检验。(生物谷Bioon.com)

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详细英文报道:

Jockeying with a slew of next-generation treatments, Novartis' ($NVS) new anti-inflammatory drug succeeded in two Phase III trials on patients with psoriatic arthritis, stoking the company's hopes of snagging significant market share once it wins approval.

The treatment, secukinumab, is an injected antibody that blocks interleukin-17A, a protein that plays a major role in inflammation. In two trials involving more than 1,000 patients combined, Novartis' drug met its primary and secondary endpoints, beating out placebo in relieving symptoms of psoriatic arthritis (PsA), preventing joint damage and maintaining clear skin, the company said. Secukinumab was well-tolerated in both studies, notching a safety profile in line with earlier trials, Novartis said.

Now the Swiss drugmaker is plotting to file for FDA and European approvals in PsA next year. The company already has pending secukinumab applications in psoriasis, for which it expects to win approval by early 2015.

Novartis believes its antibody can provide a valuable alternative to the standard of care, blockbuster anti-TNF treatments like Enbrel and Humira, pointing out that patient response to such drugs tends to diminish over time.

"Effective new therapies are urgently needed for newly PsA-diagnosed patients and for nearly half of PsA patients who are dissatisfied with or not responding to their current treatments," Novartis Global Head of Development Vasant Narasimhan said in a statement.

But Novartis will have to worry about more than just the standard of care if and when it launches secukinumab for psoriasis and PsA. As of this week, Celgene's ($CELG) TNF-targeting pill Otezla is approved for both indications, and Amgen ($AMGN) and AstraZeneca ($AZN) are working up an IL-17A inhibitor called brodalumab that has charted excellent Phase III results in both diseases. Meanwhile, Eli Lilly ($LLY) is in the midst of Phase III with the similar ixekizumab, trailed by Merck's ($MRK) MK-3222 and Johnson & Johnson's ($JNJ) guselkumab.

Beyond its top two indications, secukinumab is also in development for ankylosing spondylitis and rheumatoid arthritis, with filings for those conditions expected in 2015. If Novartis can pull off all four approvals for its antibody, analysts have speculated that the drug could clear $1 billion in annual sales by 2020.

 

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