2014年10月17日讯 /生物谷BIOON/ --诺华公司最近似乎喜事不断，先是公司开发的心衰药LCZ696研究取得了可喜进展，然后公司开发的用于治疗牛皮癣等疾病的抗炎症药物secukinumab又出现了重大突破。
最近FDA的相关专家在非正式场合表现出对这一药物的青睐有加。作为一种抗炎症药物，secukinumab是一种注射用抗体药物，它能够有效阻断IL-17，以达到治疗效果。最近诺华公司公布的临床三期研究显示，这一药物显著改善了牛皮癣患者的病情，并击败了安进公司治疗牛皮癣的长效药物Enbrel。
FDA的相关评审委员会将于下周正式对这一药物进行审核，以决定这一疗法是否能如愿进入市场。明年一月份，FDA将正式作出决定是否批准secukinumab上市。一旦诺华公司如愿以偿，secukinumab将成为首个进入牛皮癣市场的抗IL-17药物，这也使得诺华公司将有望成为炎症药物市场的又一黑马。此外，诺华公司似乎并不满足于仅仅将secukinumab推向牛皮癣药物市场。研究人员目前正在着手进行secukinumab治疗强直性脊柱炎和风湿性关节炎的研究。一旦成行，分析人士估计这一药物的年销售总额将有望达到10亿美元。
然而，单就牛皮癣市场来说，或许secukinumab的优势只会是昙花一现，因为许多生物技术公司目前正在进行IL-17类抗炎症药物的研发。如安进和阿斯利康公司的brodalumab、礼来公司的ixekizumab、默沙东公司的MK-3222和强生公司的guselkumab等都已经处于临床三期研究。
详细英文报道：
The benefits of Novartis' ($NVS) new anti-inflammatory treatment outweigh its risks, according to FDA reviewers, an opinion that improves the odds of approval for a drug the company hopes can bring in blockbuster sales.
The treatment, secukinumab, is an injected antibody that blocks interleukin-17, a protein that plays a major role in inflammation. In documents released ahead of panel meeting, FDA staff heralded its effects on psoriasis, noting that, across a 3,300-patient Phase III program, secukinumab significantly reduced symptoms of the skin ailment while charting an adverse event profile in line with placebo.
Next week, a panel of FDA advisers will weigh in on the treatment, voting whether to recommend it for full approval. The agency is due to hand down a final decision on secukinumab by January.
If, as expected, Novartis' drug wins approval, the company will be the first to market with an IL-17 therapy, leading a class of promising treatments that could improve the standard of care for psoriasis, psoriatic arthritis and other inflammatory diseases. In an earlier Phase III trial, secukinumab beat out Amgen's ($AMGN) Enbrel, an anti-TNF drug that brought in about $8.8 billion last year, highlighting its potential to be an immediate disrupter on the market.
But any IL-17 exclusivity will likely be short-lived, as a cadre of rivals are gearing up for regulatory submissions in 2015. Behind secukinumab is Amgen and AstraZeneca's ($AZN) brodalumab, a similar treatment that has notched impressive Phase IIII 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) guselkumab.
Novartis has psoriatic arthritis ambitions of its own, last month unveiling results from two Phase III trials in which secukinumab relieved symptoms, prevented joint damage and helped maintain clear skin.
Beyond its top two indications, secukinumab is also in development for ankylosing spondylitis and rheumatoid arthritis, with filings for those conditions expected next year. 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.