2014年10月22日讯 /生物谷BIOON/ --在即将过去的十月份里，诺华公司可谓好消息不断。先是公司开发的CAR-T肿瘤疗法取得积极进展，然后是公司开发的治疗牛皮癣药物secukinumab临床三期研究取得重大进展。本周，美国FDA下属的专家评审委员会全票通过了对secukinumab的审核，建议FDA正式批准其上市。一般而言，经过这一委员会批准的药物最终都会被FDA批准进入市场销售。这也意味着，诺华公司已经扫除了secukinumab上市的最后一个障碍。FDA预计将于明年一月份正式决定是否允许secukinumab上市。
诺华公司开发的药物secukinumab是一种通过特异性阻断IL-17治疗牛皮癣的注射用蛋白药物。而一旦FDA批准其上市，secukinumab就将成为治疗牛皮癣类药物市场中第一个IL-17阻断剂药物。目前，牛皮癣市场上的主要产品都是TNF抑制剂类药物。
诺华公司对这一产品寄予厚望。公司高层相信这secukinumab一旦进入市场将极大地改变市场格局。举例来说，根据相关市场调查公司的分析报告显示，52％的牛皮癣患者对市场上现有药物的疗效不满，消费者希望能出现更有效的药物产品。而此前secukinumab在临床三期研究中，击败了安进公司治疗牛皮癣的明星药物Enbrel（同样是抗TNF药物，2013年销售额达到88亿美元）也给诺华公司以更大的野心和底气。
不过也有分析人士在此前就指出，诺华公司的secukinumab并非稳操胜券，因为多家生物医药巨头都已经对这一市场虎视眈眈。如强生、默沙东等公司都正在开发自己的治疗牛皮癣药物。（相关阅读：FDA专家对诺华牛皮癣药物青睐有加）因此，这场牛皮癣市场的竞争，究竟鹿死谁手还需要时间的检验。
详细英文报道：
A panel of FDA advisers voted unanimously in favor of approving Novartis' ($NVS) new anti-inflammatory treatment, an expected positive outcome for the company as it races to be first in line among what promises to be a crowded field.
Novartis' treatment, secukinumab, is an injected antibody that blocks interleukin-17, a protein that plays a major role in inflammation. The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 7-0 that the company's pivotal data support the approval of secukinumab to treat plaque psoriasis, the first of Novartis' desired indications.
The FDA isn't beholden to follow the whims of its advisers, though it commonly does, and the agency is due to hand down a final decision on secukinumab's future in psoriasis in January.
If Novartis' drug wins approval, it'll be the first IL-17 blocker to hit the market, leading a pack of new treatments that could improve the standard of care for psoriasis, psoriatic arthritis and other inflammatory diseases.
Currently, the most common option for psoriasis sufferers are injected therapies that inhibit tumor necrosis factor (TNF), treatments that have brought in blockbuster sales. But Novartis believes its contender can disrupt the market, pointing to a National Psoriasis Foundation survey in which 52% of patients surveyed said they were dissatisfied with their disease management. And the company has plenty of data to back up its case for secukinumab, including results from a Phase III psoriasis trial in which the treatment beat out Amgen's ($AMGN) Enbrel, an anti-TNF drug that brought in about $8.8 billion last year.
"We are pleased with today's unanimous recommendation, which is based on the efficacy and safety data put forth in our robust clinical trial program, and the advisory committee decision brings us one step closer to delivering an innovative, new treatment option for people suffering from moderate-to-severe psoriasis," Novartis Global Head of Development Vas Narasimhan said in a statement. "There is a need for novel therapies, as not all treatments are appropriate or effective in every patient."
But while Novartis will likely be first to the IL-17 market, it's soon to be joined by a slew of other anti-inflammatory biologics targeting the same multibillion-dollar space. Behind secukinumab is Amgen and AstraZeneca's ($AZN) brodalumab, a similar treatment that has notched impressive Phase III results in psoriasis and psoriatic arthritis. 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 ($JNJ) IL-23 inhibitor guselkumab, which is set to enter Phase III this quarter.
Novartis has psoriatic arthritis ambitions of its own, last month unveiling results from two Phase III trials in which secukinumab relieved symptoms of that disease, preventing joint damage and helping to maintain clear skin. Beyond the two leading indications, secukinumab is also in development for ankylosing spondylitis and rheumatoid arthritis, with filings for those conditions expected next year.
If the company can pull off all four approvals for its antibody, analysts have speculated that the drug could clear $1 billion in annual sales by 2020.