重磅药物Otezla——FDA批准新基Otezla治疗斑块型银屑病

      2014年9月25日讯 /BIOON/ --生物技术巨头新基(Celgene)在2013年凭借其明星药物Abraxane(注射用紫杉醇[白蛋白结合型])着实风光了一把，该药是一种化疗药物，因乔布斯之死和癌中之王——胰腺癌适应症而名声大噪。今年，Celgene又收获了一枚重磅药物Otezla，该药6个月内接连收获2个适应症，与市售药物相比，Otezla具有无需监测及口服的巨大优势，业界预测，Otezla的年销售峰值将突破20亿美元。
　　新基(Celgene)近日宣布，口服药物Otezla(apremilast)获FDA批准，用于适合光疗和系统疗法的中度至重度斑块型银屑病(Plaque Psoriasis)成人患者的治疗。Otezla是一种口服、选择性磷酸二酯酶4(PDE4)抑制剂，该药是FDA批准的首个也是唯一一个用于斑块型银屑病治疗的PDE4抑制剂。
　　Otezla将为广泛的斑块型银屑病患者群体提供一种有价值的治疗选择，包括以前使用过生物制剂或常规系统性药物治疗的患者群体。银屑病(psoriasis)是一种由不受控免疫反应导致的皮肤慢性炎症性疾病，全球患者总数超过1.25亿人。
　　Otezla的获批，是基于2项研究(ESTEEM-1和ESTEEM-2)的主要疗效和安全性数据。这2项研究均为多中心、随机、双盲、安慰剂对照研究，在中度至重度斑块型银屑病(Plaque Psoriasis)成人患者中开展。研究中，Otezla使患者斑块型银屑病病情取得了显著且具有临床意义的改善。此前，FDA已于今年3月批准Otezla用于活动性银屑病性关节炎(PsA)成人患者的治疗。
　　Otezla销售峰值超20亿美元
　　业界认为，尽管面临着注射型药物肿瘤坏死因子(TNF)抑制剂的竞争，尤其是艾伯维的Humira(阿达木单抗)和辉瑞/安进的Entrel(etanercept)，但Otezla用药不需要常规的实验室监测，且是一种口服药物，相比市售药物，Otezla具有巨大优势，将为患者和医生提供一种重要的治疗选择。
　　EvaluatePharma此前预测，Otezla在2018年的销售额将达到12.19亿美元，而此次FDA批准Otezla新适应症，业界预期，Otezla的销售峰值有望突破20亿美元。
　　关于Otezla(apremilast)：
　　Otezla(apremilast)是一种口服小分子磷酸二酯酶(PDE4)抑制剂，在细胞内调控促炎症和抗炎介质的网络。PDE4是一种环磷酸腺苷(cAMP)特异性PDE，是炎性细胞中主要的PDE。PDE4抑制可提升细胞内cAMP水平，通过调控TNF-α、IL-23和其他炎性细胞因子的表达相应下调炎性反应。cAMP升高也会增加抗炎细胞因子，例如IL-10。

眼看近几年外国药大踏步前进，不禁想高呼，中国队加油！

英文原文：Oral OTEZLA? (apremilast) Approved by the U.S. Food and Drug Administration for the Treatment of Patients with Moderate to Severe Plaque Psoriasis
　　In phase III studies, OTEZLA resulted in significant and clinically meaningful improvements in plaque psoriasis
　　OTEZLA demonstrated a consistent safety and tolerability profile across clinical trials
　　SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA? (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. OTEZLA is the first and only PDE4 inhibitor approved for the treatment of plaque psoriasis. Psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response, affects more than 125 million people worldwide.
　　"OTEZLA offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments. In clinical trials, OTEZLA reduced redness, thickness, and scaliness of plaques in patients with moderate or severe plaque psoriasis," said Dr. M. Shane Chapman, Section Chief of Dermatology at Dartmouth-Hitchcock Medical Center. "Because the product labeling does not require routine laboratory monitoring, oral OTEZLA may be a welcome new option for patients and physicians looking for a different treatment experience."
　　The approval of OTEZLA was based primarily on safety and efficacy results from two multi-center, randomized, double-blind, placebo-controlled studies - ESTEEM 1 and ESTEEM 2 - conducted in adult patients with moderate to severe plaque psoriasis: body surface area (BSA) involvement of ≥10%, static Physician Global Assessment (sPGA) of ≥3 (moderate or severe disease), Psoriasis Area and Severity Index (PASI) score ≥12, and candidates for phototherapy or systemic therapy.
　　"OTEZLA offers a valuable treatment option for a spectrum of plaque psoriasis patients - patients who are treatment-na?ve as well as patients who are treatment-experienced, including those previously treated with biologic agents or conventional systemic agents," said Scott Smith, President Inflammation & Immunology for Celgene Corporation. "The FDA approval of OTEZLA for plaque psoriasis, together with the previous approval for psoriatic arthritis, reflects Celgene's commitment to extending the reach of our research and science in an effort to improve the lives of people worldwide living with chronic inflammatory diseases."
　　In the ESTEEM studies, OTEZLA treatment resulted in significant and clinically meaningful improvements in plaque psoriasis as measured by PASI scores at week 16. Clinical improvement as measured by sPGA scores of clear to almost clear were also demonstrated in both studies.
　　The safety of OTEZLA was assessed in 1,426 patients from three clinical trials. Side effects of OTEZLA were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache. Before starting OTEZLA, patients should inform their doctor if they have a history of depression or suicidal behavior and if these conditions or other mood changes develop or worsen while taking OTEZLA. Patients taking OTEZLA should have their weight checked regularly.
　　"soriasis is a serious autoimmune disorder commonly associated with comorbidities," said Randy Beranek, president and CEO, National Psoriasis Foundation. "Effectively treating psoriasis is an important part of managing a patient's overall health. Having a new treatment like OTEZLA is important so patients can have more options and can work closely with their providers to find what works best for them."
　　OTEZLA? is available in the U.S. and is dispensed through a comprehensive network of specialty pharmacies. For more information about OTEZLA distribution and the exclusive treatment support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact Otezla SupportPlus? at 1-844-4OTEZLA (1-844-468-3952) or visitwww.OTEZLA.comfor more information.
　　OTEZLA was approved on March 21, 2014 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with active psoriatic arthritis. A New Drug Submission (NDS) for psoriatic arthritis was submitted to health authorities in Canada in the second quarter of 2013. A NDS for psoriasis in Canada as well as a combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) in Europe were all submitted to health authorities in the fourth quarter of 2013.

好消息.但可望而不可即.

不知国内何时引进

中国队加油！中国队加油！

刚看完上面的中国仿制药，就看到外国又开发了新药，只可惜中国药企还得登上10年20年才能赚我们P友的钱，要是没有保护法，那些山寨劣等药恐怕早就上市了，20年后的同族会遭遇什么呢。

QUOTE:

以下是引用年薪十万吃面在2014-9-30 13:35:00的发言：
在生物制剂的新特药方面，中国药企就是国足，不是不想射，是真没有能射的。

比喻恰当[em80]

在生物制剂的新特药方面，中国药企就是国足，不是不想射，是真没有能射的。

新消息好消息越来越多，是不是离我们脱离痛苦越近一步呢。