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罗氏皮下注射剂型Actemra获FDA批准

来源:生物谷 2013-10-25 07:13

2013年10月24日讯 /生物谷BIOON/ --罗氏(Roche)皮下注射剂型Actemra(通用名:tocilizumab)获FDA批准,用于既往经一种或多种疾病修饰抗风湿药物(DMARDs)治疗反应不足的中度至重度活动性类风湿性关节炎(RA)成人患者的治疗。此次批准,是Actemra在4年内获得的第6个FDA批准,此前FDA已批准Actemra用于中度至重度活动性类风湿性关节炎成人患者的治疗、用于2岁及以上活动性多关节幼年特发性关节炎和全身型幼年特发性关节炎的治疗。

与静脉注射剂型Actemra一样,皮下注射剂型Actemra可用作单药疗法,也可与甲氨蝶呤(MTX)或其他非生物类DMARDs联合用药。罗氏计划于11月初将皮下注射剂型配方Actemra推向市场。

FDA曾于2010年批准Actemra作为一种静脉注射(IV)药物,目前,该药是首个也是唯一一个获FDA批准可静脉滴注给药(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。

皮下注射剂型Actemra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)Actemra(162mg/周),达到了与静脉注射剂型(intravenous,IV)Actemra(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(Actemra SC vs Actemra 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Actemra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,Actemra 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 Gains FDA Approval for New Subcutaneous Formulation of ACTEMRA for Use in Adult Patients Living with Moderately to Severely Active Rheumatoid Arthritis

-This is the sixth FDA approval for ACTEMRA in four years, following previous approvals for the treatment of adults with moderately to severely active rheumatoid arthritis and children two years of age and older with active polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

-ACTEMRA is now approved as a subcutaneous formulation to treat adult patients with moderately to severely active rheumatoid arthritis who have used one or more disease-modifying antirheumatic drugs, such as methotrexate, that did not provide enough relief.

-ACTEMRA is the first and only humanized interleukin-6 receptor-antagonist monoclonal antibody approved by the FDA for both subcutaneous and intravenous administration in rheumatoid arthritis.

Roche today announced that the U.S. Food and Drug Administration (FDA) has approved a subcutaneous formulation of ACTEMRA (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), who have used one or more disease-modifying antirheumatics drugs (DMARDs), such as methotrexate, that did not provide enough relief. Like the intravenous (IV) formulation, the subcutaneous (SC) formulation can be used both as a single-agent therapy and in combination with methotrexate or other non-biologic DMARDs. The ACTEMRA pre-filled syringe injection formulation will be available in early November.

"People with moderately to severely active rheumatoid arthritis can suffer irreversible joint damage that may be prevented by earlier treatment with a medicine such as Actemra," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We're pleased that these patients will now have the option of Actemra as a subcutaneous injection or an IV infusion."

ACTEMRA, originally approved by the FDA as an IV medicine in 2010, is the first and only humanized interleukin-6 (IL-6) receptor-antagonist monoclonal antibody approved by the FDA for both SC and IV administration.

The approval is based on data from the phase III clinical trials SUMMACTA and BREVACTA. For ACTEMRA SC, the FDA recommended dosage is 162 mg administered subcutaneously every other week, followed by an increase to 162 mg every week based on clinical response for patients less than 100 kg (220 lbs) in weight. For patients at or above 100 kg (220 lbs), the dosing is 162 mg administered subcutaneously every week.

About SUMMACTA

SUMMACTA is a randomized, double-blind, active controlled, parallel group, multicenter study with a double-blind period of 24 weeks in 1,262 patients with moderately to severely active RA. SUMMACTA demonstrated comparable efficacy (non-inferiority) of the SC formulation of ACTEMRA162 mg given weekly plus DMARDs compared to 8 mg/kg of ACTEMRA given intravenously every four weeks plus DMARDs in patients with moderately to severely active RA in the DMARD-IR population (20 percent of whom had inadequate response to anti-tumor necrosis factor [anti-TNF] therapy). A similar proportion of RA patients in each group experienced at least a 20 percent improvement in tender and swollen joints (American College of Rheumatology [ACR] 20 response) at Week 24 (69 percent with ACTEMRA SC formulation vs. 73 percent with ACTEMRA IV).

Analysis of safety at Week 24 showed that the adverse event profile of the SC and IV groups were comparable, except for SC injection site reactions.

About BREVACTA

BREVACTA is a randomized, double-blind, parallel-group study of ACTEMRA SC versus placebo SC in combination with traditional DMARDs in patients with moderately to severely active RA, who had an inadequate response to DMARD therapy. In the study, 656 patients were randomly assigned in a 2:1 ratio to two treatment groups receiving ACTEMRA SC every two weeks administered with a pre-filled syringe and placebo SC every two weeks with a pre-filled syringe. All patients continued their background DMARD therapy.

Results from BREVACTA showed RA patients who received the SC formulation of ACTEMRA every two weeks plus DMARDs were significantly more likely to have achieved ACR20 response than those given placebo SC plus DMARDs at 24 weeks (61 percent vs. 32 percent, respectively). At Week 24, significantly less structural joint damage progression was observed in patients receiving ACTEMRA SC plus DMARDs compared to placebo plus DMARDs as assessed radiographically and expressed as a change from baseline in the van der Heijde modified total Sharp score (mTSS) (mean change from baseline in mTSS of 0.62 vs. 1.23, respectively, with an adjusted mean difference of -0.60 [-1.1, -0.1]). No new clinically meaningful safety signals for ACTEMRA, except SC injection site reactions, were observed in this study.

About rheumatoid arthritis

RA is an autoimmune disease estimated to affect up to 70 million people worldwide.1 Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged.2

About ACTEMRA (tocilizumab)

ACTEMRA, known as RoACTEMRA outside the U.S., is the first humanised interleukin-6 (IL-6) receptor agonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, that did not provide enough relief. The extensive ACTEMRA clinical development programme 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 ACTEMRA was superior to monotherapy with adalimumab in reducing signs and symptoms of RA in methotrexate-intolerant patients or patients for whom methotrexate treatment was considered ineffective or inappropriate.3 The overall safety profile of both medications was consistent with previously reported data. 3

ACTEMRA is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older.

ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd. It has been approved in Japan since April 2005 for Castleman's disease, followed by approvals for RA, SJIA and PJIA in 2008. It is approved in the European Union, and several other countries, including the United States, China, India, Brazil, Switzerland and Australia.

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