201年1月20日讯 /生物谷BIOON/ --瑞士制药巨头诺华（Novartis）收获重磅消息！单抗药物Cosentyx（secukinumab）近日获欧盟批准，用于中度至重度斑块型银屑病（plaque psoriasis）成人患者的治疗。Cosentyx是全球首个白介素17A（IL-17A）单抗，该药的获批标志着银屑病临床治疗的重大里程碑，将为广大银屑病群体提供一个重要的一线生物治疗选择。
在欧洲，目前所有治疗银屑病的生物制剂（包括抗肿瘤坏死因子疗法（anti-TNFs）及ustekinumab），均被推荐作为二线系统性疗法。而Cosentyx的上市，意味着欧洲医生可以使用Cosentyx取代其他具有显著副作用的一线系统疗法用于银屑病患者的一线治疗。
当前，银屑病市场由TNF阻断剂（抗肿瘤坏死因子单抗）统治，然而有高达40%的患者对TNF阻断剂治疗不足或无反应。而IL-17阻断剂的上市，将极大地改善银屑病、银屑病关节炎及其他炎症性疾病的临床标准护理。
尽管诺华Cosentyx是上市的首个IL-17阻断剂，然而，分析师预计，该市场将很快迎来其他竞争产品，紧跟其后的是安进和阿斯利康开发的类似药物brodalumab，该药在银屑病和银屑病关节炎III期临床中均创下了骄人的成绩。此外，礼来的IL-17阻断剂ixekizumab和默沙东的MK-3222及强生（JNJ）的IL-23阻断剂guselkumab也已进入III期临床开发。
在全球其他市场中，Cosentyx于2014年12月中旬获日本批准用于中度至重度斑块型银屑病和活动性银屑病关节炎（PsA）的治疗，同时Cosentyx也获得澳大利亚批准用于斑块型银屑病的治疗。而美国市场，诺华预计FDA将在2015年初批准Cosentyx。
目前，诺华正在调查secukinumab用于多种炎症疾病的治疗，包括银屑病、银屑病关节炎、强直性脊柱炎（AS）和类风湿性关节炎（RA）。业界预测，如果这4个适应症均获批，secukinumab到2020年的销售额将突破10亿美元。
去年10月，secukinumab在强直性脊柱炎（AS）2个关键III期研究（MEASURE-1，MEASURE-2）获得成功，研究中secukinumab显著改善了疾病的症状和体征，同时也显著改善了患者的身体机能和生活质量。该研究成果也标志着secukinumab成为首个在强直性脊柱炎（AS）III期临床获得成功的IL-17A阻断剂。这2项研究中，secukinumab的安全性与该药在银屑病大型III期项目中的安全性一致。诺华已计划在2015年提交secukinumab治疗银屑病关节炎（PsA）和强直性脊柱炎（AS）的监管申请。
英文原文：Novartis Cosentyx(TM) is the first IL-17 inhibitor to receive EU approval for first-line treatment of moderate-to-severe psoriasis patients
-Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects[1]; all other biologics are recommended for second-line therapy[2-4]
-Cosentyx showed superiority to Stelara® in the Phase IIIb CLEAR study[5]
In Phase III studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment[6]
-Achieving clear skin is the ultimate treatment goal for patients with psoriasis; 50% of psoriasis patients are not content with current therapies[7-10]
Basel, 19 January 2015 - Novartis announced today that the European Commission (EC) has approved Cosentyx(TM) (secukinumab, formerly known as AIN457) as a first-line systemic* treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.
Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe and this approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and Stelara®** (ustekinumab) are recommended for second-line systemic therapy in Europe[2-4].
"With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis," said David Epstein, Division Head, Novartis Pharmaceuticals. "Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin."
The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52[6]. Data from the Cosentyx clinical trial program also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life[11].
The EU approval follows the recent results of the Phase IIIb CLEAR study, which showed that Cosentyx was superior to Stelara®** in clearing skin of patients living with moderate-to-severe plaque psoriasis. The CLEAR study was the second head-to-head study for Cosentyx. Cosentyx also showed superiority to Enbrel®*** (etanercept) in clearing skin in the FIXTURE study[6]. In the Phase III clinical program the overall safety profile of Cosentyx was favorable, with minimal differences seen between etanercept and ustekinumab in head-to-head comparison[5,6].
In addition to the EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).
The US Food and Drug Administration (FDA) decision in moderate-to-severe plaque psoriasis is anticipated early in 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.
About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a human monoclonal antibody that selectively neutralizes IL-17A[12,13]. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies[12-17]. Cosentyx works by inhibiting the action of interleukin-17A (IL-17A), a protein found in high concentrations in skin affected by the disease[12-17]. In the Phase III program, Cosentyx demonstrated a favorable safety profile, with similar incidence and severity of adverse events between secukinumab treatment arms (300 mg and 150 mg)[5,18-20].
Phase IIIb studies in psoriasis are ongoing in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis.
Cosentyx is also in Phase III development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS); regulatory applications are planned for 2015.
About Psoriasis
Psoriasis is a chronic immune-mediated disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain; it is associated with significant impairment of physical and psychological quality of life[7,21,22]. Psoriasis affects up to 3% of the world's population, or more than 125 million people[23]. In Europe, the estimate is about 0.8%, which means that plaque psoriasis affects about 3.7 million Europeans, with about 2.4 million considered to have moderate-to-severe disease[24].
This common and distressing condition is not simply a cosmetic problem - even people with very mild symptoms are affected everyday[7]. Furthermore, there is an urgent need for new psoriasis treatments, as up to 50% of patients are not content with current therapies, including biologic treatments[7-10].