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罗氏皮下注射剂型RoACTEMRA获欧盟批准

2014年4月28日讯 /生物谷BIOON/ --罗氏(Roche)4月28日宣布,皮下注射(subcutaneous,SC)剂型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已于2013年10月获FDA批准,商品名为ACTEMRA SC。

皮下注射剂型RoACTEMRA的获批,是基于III期临床试验SUMMACTA和BREVACTA研究的数据:

SUMMACTA是一项随机、双盲、活性药物对照、平行组、多中心III期临床研究,在1262例中度至重度活动性RA患者中开展。研究结果表明,皮下注射剂型(subcutaneous,SC)RoACTEMRA(162mg/周),达到了与静脉注射剂型(intravenous,IV)RoACTEMRA(8mg/kg/4周)相媲美的疗效,各组在24周时达到ACR20反应的患者比例相似(RoACTEMRA SC vs RoACTEMRA IV :69% vs 73% )。 24周时的安全性分析表明,除SC组注射部位反应外,SC组和IV组不良事件相当。

BREVACTA是一项随机、双盲、平行组III期研究,调查了皮下注射剂型RoACTEMRA联合DMARDs用于治疗中度至重度活动性类风湿性关节炎患者时相对于安慰剂和DMARDs的疗效和安全性。研究结果表明,与安慰剂+DMARDs治疗组相比,RoACTEMRA SC+DMARDs治疗组有更多的患者达到ACR20反应(61% vs 32%)。该项研究中,除注射位点反应外,未发现临床意义的新安全信号。(生物谷Bioon.com)

英文原文:Roche receives EU approval for new subcutaneous formulation of RoACTEMRA providing more treatment flexibility for patients with moderate to severe rheumatoid arthritis

Basel, 28 April 2014

Roche receives EU approval for new subcutaneous formulation of RoACTEMRA providing more treatment flexibility for patients with moderate to severe rheumatoid arthritis

First anti IL-6 receptor biologic now available for subcutaneous and intravenous administration for both monotherapy and combination therapy

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the subcutaneous formulation of RoACTEMRA (tocilizumab) has received approval from the European Commission for the treatment of moderate to severe rheumatoid arthritis (RA) in patients who are either intolerant to or have failed to respond to other RA treatments. This approval makes RoACTEMRA the first anti IL-6 receptor biologic available as subcutaneous and intravenous (IV) formulations for both monotherapy and combination therapy with methotrexate (MTX). It is the fourth update to RoACTEMRA’s European label and significantly expands the number of patients who now have access to RoACTEMRA.

“Today’s European approval of RoActemra is important because it provides physicians and patients with the flexibility to choose a treatment method that suits their needs,” said Sandra Horning, M.D., Head of Global Product Development and Chief Medical Officer at Roche. “Together with their physicians, patients can choose whether to self-inject RoACTEMRA at home or have it administered in their doctor’s office.”

The approval was based on data from the phase III SUMMACTA and BREVACTA studies.1,2 SUMMACTA showed that the efficacy and tolerability of subcutaneous RoACTEMRA was comparable with intravenous RoACTEMRA.1 In addition, subcutaneous RoACTEMRA demonstrated long-term efficacy and reduced progression of joint damage over 48 weeks compared to placebo in the BREVACTA study.2 The subcutaneous formulation of RoACTEMRA will be available via a prefilled syringe. It was approved in Japan and the United States in 2013.

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 anti-rheumatic drug (DMARD).6,7

About RoACTEMRA (tocilizumab)

RoACTEMRA is the first humanized interleukin 6 (IL-6) receptor-antagonist monoclonal antibody approved for use in combination with or without methotrexate, 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

The extensive RoACTEMRA 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 IV 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.9 The overall safety profile of both medications was consistent with previously reported data. This data was recognised in the recent European League Against Rheumatism recommendations for the management of RA, where RoACTEMRA was recommended as a first-line biologic and was highlighted for use as monotherapy.6

RoACTEMRA IV 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.8

RoACTEMRA is part of a co-development agreement with Chugai Pharmaceutical. It has been approved in Japan since April 2005 for Castleman’s disease, followed by approvals for RA, SJIA and PJIA in 2008. More than 275,000 patients have been treated with RoACTEMRA since it first launched. RoACTEMRA is approved in more than 100 countries worldwide including countries in the European Union, the United States, China, India, Brazil, Switzerland and Australia. It is available in more than 90 of these countries.

About Roche in immunology

The Roche Group’s immunology medicines include rheumatoid arthritis treatments MabThera/Rituxan(rituximab) and ACTEMRA/RoACTEMRA (tocilizumab), XOLAIR (omalizumab) in asthma and Pulmozyme (dornase alfa) for cystic fibrosis. In addition to its approved portfolio of immunology medicines, Roche late stage pipeline products include etrolizumab being studied in ulcerative colitis and lebrikizumab for severe asthma.

关键词:RoACTEMRA,罗氏,皮下注射剂型,tocilizumab,托珠单抗,类风湿性关节炎

信息来源:生物谷