欧盟批准罗氏RoACTEMRA治疗早期类风湿性关节炎

欧盟批准罗氏RoACTEMRA治疗早期类风湿性关节炎

                               
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发布日期：2014-09-11  来源：生物谷  

罗氏单抗RoACTEMRA获欧盟批准用于早期RA治疗。业界预测，2022年全球RA市场将达158亿美元，鉴于Cimzia和Humira的存在，罗氏在RA市场面临的竞争仍将非常激烈。

                               
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罗氏（Roche）近日宣布，单抗药物RoACTEMRA（欧洲以外名为ACTEMRA，通用名：tocilizumab，托珠单抗）获欧盟委员会（EC）批准，用于既往未接受过甲氨蝶呤（MTX）治疗的重度活动性进行性类风湿性关节炎（RA）患者的治疗。

在确诊的前2年内（早期RA），重度进行性类风湿性关节炎的治疗至关重要，可防止关节的不可逆损伤及病情的进一步恶化甚至长远的致残。RoACTEMRA是欧盟批准用于早期RA治疗的首个白介素-6（IL-6）受体拮抗剂。此次批准，也是RoACTEMRA在3年内欧盟标签的第5个更新和扩展。

RoACTEMRA的获批，是基于III期FUNCTION研究的积极数据，该项研究调查了RoACTEMRA治疗既往未接受甲氨蝶呤（MTX）疗法的早期中度至重度RA（定义为确诊2年内的RA）患者的疗效、安全性、以及对结构性关节损伤的预防。数据表明，经24周治疗后，与MTX治疗组相比，RoACTEMRA+MTX联合治疗组和RoACTEMRA单药治疗组，患者疾病活动（DAS28缓解）得到了统计学意义的显著改善，同时更大程度地抑制了结构性关节损伤，达到了研究的主要终点。

今年4月，欧盟已批准皮下注射（SC）剂型RoACTEMRA，用于既往经一种或多种疾病修饰抗风湿药物（DMARDs）或肿瘤坏死因子（TNF）抑制剂治疗反应不足、或对这些药物不耐受的中度至重度活动性类风湿性关节炎（RA）成人患者的治疗，这是RoACTEMRA欧洲标签的第4个更新，将显著扩大该药的患者群体。

此次获批，使RoACTEMRA成为首个也是唯一一个可静脉滴注给药（IV）和皮下注射给药（SC）的人源化白细胞介素6受体拮抗剂单克隆抗体。与静脉注射（intravenous，IV）剂型一样，皮下注射剂型RoACTEMRA可作为单药疗法，同时也可与甲氨蝶呤（MTX）或其他非生物类DMARDs联合用药。此前，皮下注射剂型RoACTEMRA也已于2013年10月获FDA批准，商品名为ACTEMRA SC。在美国市场，ACTEMRA销售额在2014上半年同比增长22%

据Decision Resources调研报告，美国、日本、欧盟5大主要市场（英国、法国，意大利、西班牙和德国）类风湿关节炎（RA）药物市场将会从2012年的123亿美元增长到2022年的158亿美元。然而，尽管市场前景看好，但鉴于市面上优时比（UCB）重磅产品Cimzia（聚乙二醇化赛托珠单抗，certolizumab pegol）以及艾伯维（AbbVie）RA明星药物修美乐（Humira，通用名：阿达木单抗）的存在，罗氏面临的竞争仍将非常激烈。

英文原文：Roche¡ˉs RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis (RA)

Treating RA patients with severe, progressive disease in the first two years after diagnosis (early RA) could prevent damage to joints and stop the disease from progressing1,2

RoACTEMRA with and without MTX achieved greater inhibition of structural joint damage compared with MTX alone in the early RA population1

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that RoACTEMRA (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA who previously have not been treated with methotrexate (MTX). Treating the disease at this critical early phase may prevent irreversible damage to joints and long-term disability.1,2 RoACTEMRA is the first interleukin-6 (IL-6) receptor antagonist to be approved for use in Europe in patients with early RA.

¡°RoACTEMRA is an effective biologic treatment for patients with early RA that may change the course of disease and reduce the likelihood of disability,¡± said Sandra Horning, M.D., Head of Global Product Development and Chief Medical Officer at Roche. ¡°As the first IL-6 receptor antagonist approved for early RA, RoACTEMRA addresses the need for alternative treatment options to anti-tumor-necrosis-factor (anti-TNF) therapies in this debilitating condition.¡±

The approval was based on data from the phase III FUNCTION study, which assessed the efficacy, safety and prevention of structural joint damage in patients with early moderate-to-severe RA (defined as ¡ü2 years since diagnosis) not previously treated with MTX.1 The study met its primary endpoint, demonstrating that patients who received RoACTEMRA in combination with MTX or as a single agent therapy (monotherapy) experienced a significantly greater improvement in disease activity (DAS28 remission) after 24 weeks compared to patients who received MTX alone.1

The data also demonstrated that treatment with RoACTEMRA with and without MTX achieved greater inhibition of structural joint damage compared with MTX alone.1 At 24 weeks, the overall safety of RoACTEMRA in this early RA population was consistent with its known safety profile seen previously in other RoACTEMRA studies in RA.1

The early RA approval is the fifth updat and expansion to RoACTEMRA's European label in three years.

about Rheumatoid Arthritis

RA is an autoimmune disease with prevalence worldwide of approximately 40 million.3,4 RA causes joints to become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.5 RA patients are often treated with a number of medicines, combining protein-based biologic therapies with MTX, the most common disease-modifying antirheumatic drug (DMARD).6,7

about RoACTEMRA (tocilizumab)

RoACTEMRA is the first humanized anti-interleukin 6 (IL-6) receptor antagonist monoclonal antibody approved for use in combination with or as monotherapy without MTX, for the treatment of moderate-to-severe RA in adult patients who have either responded inadequately to, or who are intolerant to, previous therapy with one or more DMARDs or tumor necrosis factor (TNF) antagonists.8 RoACTEMRA is the first anti-IL-6 approved for both monotherapy and combination use in intravenous and subcutaneous formulations.

The extensive RoACTEMRA RA clinical development program included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. In addition, the phase IV ADACTA study showed that monotherapy with RoACTEMRA was superior to monotherapy with adalimumab in reducing signs and symptoms of RA in MTX-intolerant patients or patients for whom MTX treatment was considered ineffective or inappropriate.7 The overall safety profile of both medications was consistent with previously reported data.7 This data was recognised in the recent European League Against Rheumatism recommendations for the management of RA, wher RoACTEMRA was recommended as a first-line biologic and was highlighted for use as monotherapy if patients are intolerant to MTX or conventional DMARDs.6

The RoACTEMRA intravenous formulation is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.6 The RoACTEMRA subcutaneous formulation was approved for use in adult patients in Japan, U.S. and Europe in March 2013, October 2013 and April 2014, respectively.

RoACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. It has been approved in Japan since April 2005 for Castleman¡ˉs disease, followed by approvals for RA, SJIA and PJIA in 2008. More than 300,000 patients have been treated with RoACTEMRA since it first launched. RoACTEMRA is approved in more than 100 countries worldwide including countries in the European unio, the United States, China, India, Brazil, Switzerland and Australia. It is available in more than 90 of these countries.

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