新功能、新界面、新体验,扫描即可下载生物谷APP!
首页 » 诺华 » 诺华公司牛皮癣药物secukinumab临床三期研究取得良好数据

诺华公司牛皮癣药物secukinumab临床三期研究取得良好数据

来源:生物谷 2014-03-25 13:27

2014年3月25日讯 /生物谷BIOON/ --近日生物医药巨头诺华公司透露公司正在进行的牛皮癣药物secukinumab临床三期研究进展良好,取得了一批积极的研究数据,同时用户的满意度也有所上升。事实上对于诺华的secukinumab来说,如何证明它的药效并不是一个难题。现有的研究数据已经足以说明其药效,但是诺华公司想要凭借secukinumab在市场上占据一席之地却还需要更多的优势。Secukinumab是一种IL-17A抑制物药物,它在300mg、150mg两个剂量的三期研究中都表现出了优于Enbrel的效果。不过由于目前各大药厂都纷纷开发相似的药物,如Celgene公司几天前刚刚获得批准的Otezla在去年就已经申请批准用于治疗牛皮癣,安进公司和阿斯利康公司合作开发的brodalumab也已经再2012年底进入了临床三期研究。此外礼来公司、默沙东公司都在这一领域研发着自己的产品。另一方面Enbrel的仿制药凭借低廉的价格也竞逐这一市场。因此,诺华公司的产品如果想要占据一席之地,还是需要另辟蹊径提高患者用药的满意度。(生物谷Bioon.com)

详细英文报道:

Investigators for Novartis pumped out more positive Phase III data for its psoriasis therapy secukinumab over the weekend, adding some patient satisfaction scores on the self-injected treatment as the company positions this new product against a host of rivals that promise to quickly crowd the field.

The pharma giant ($NVS) had no trouble illustrating a dramatic difference in efficacy between secukinumab (AIN457) and a placebo. The therapy had already beat out much tougher competition in a head-to-head with Enbrel and a 300 mg and 150 mg dose scored high response rates in both Phase III studies, compared with no response in the placebo arms. The data were presented at the American Academy of Dermatology in Denver.

But Novartis, which has already filed its IL-17A inhibitor for an approval, won't be competing with placebos in the marketplace. Even Enbrel isn't likely to be a long-term factor. The company's big hurdle will be facing challengers now in Phase III.

Celgene ($CELG) just won an approval for Otezla (apremilast) for psoriatic arthritis on Friday and filed its application on psoriasis last fall. Celgene went to Denver to tout new extended Phase III results for its oral therapy. Amgen ($AMGN) and AstraZeneca ($AZN) pushed their IL-17 treatment brodalumab into Phase III in the fall of 2012. In the fall of last year Amgen's Sean Harper boasted that the therapy achieved primary and secondary endpoints in Phase II, with bullish expectations for their Phase III program. Eli Lilly ($LLY) has an IL-17 drug as well, ixekizumab, which is in Phase III. Merck's ($MRK) MK-3222 is also coming along. And cheaper biosimilars of Enbrel have been pushed along by Cipla and Novartis and others.

Coming up from behind is Johnson & Johnson's ($JNJ) guselkumab, which targets  IL23p19 and is partnered with MorphoSys AG. The drug is touted as a top contender in J&J's pipeline, with a prospective approval coming in the 2015-2017 time frame. In a Phase IIb unveiled in Denver, investigators found that 86% of patients taking the 100 mg dose experienced very high clearance scores, according to Reuters. And some doses also beat out Humira.

Complicating this rivalry, all of these drugs are posting high clearance rates, making for a brutal showdown if they all get to the marketplace.

That's one reason why Novartis highlighted patient satisfaction in self-administering the drug with a pre-filled syringe or autoinjector pen. This condition afflicts some 125 million people and patient satisfaction on an easy delivery method will be crucial to its success on the market.

"Treating psoriasis can be challenging as not all treatments are appropriate or effective in every patient," said Dr. Andrew Blauvelt, an investigator in the secukinumab clinical trial program, in a statement. "The clinical data we have seen with secukinumab suggest it may offer a new therapeutic approach for patients living with moderate-to-severe plaque psoriasis."

Tim Anderson at Bernstein has estimated that the Big Pharma companies are angling for a market likely to deliver anywhere from $500 million to $700 million a year for each product by 2020, with Novartis coming out on the top of that range. Some analysts expect that new psoriasis treatments could double the overall market by 2022.

 

温馨提示:87%用户都在生物谷APP上阅读,扫描立刻下载! 天天精彩!


相关标签

最新会议 培训班 期刊库