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Subcutaneous RoACTEMRA receives European approval for patients with moderate to severe rheumatoid arthritis

Roche has announced that the subcutaneous formulation of RoACTEMRA (tocilizumab) has received approval from the European Commission for the treatment of moderate to severe (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.

Ralf Keil, Lifecycle Leader RoACTEMRA – “The majority of patients with rheumatoid arthritis on a first-line biologic receive their treatment by . Roche recognize the importance to patients of having flexibility to choose treatments that are right for them, and have responded by offering a new option for those who favor . This latest EU approval for RoACTEMRA makes this option available to address the needs and preferences of both patients and physicians.”

Prof. Dr Gerd Burmester, Clinical Rheumatologist at the Charit√© Universit√§tsmedizin, Berlin and President-elect EULAR – “The availability of both subcutaneous and IV formulations of RoACTEMRA means that people living with rheumatoid arthritis over the long-term can continue to benefit from meaningful improvements, regardless of how it is delivered. The convenience of subcutaneous administration gives people with rheumatoid arthritis a time-saving treatment option of a self-administered injection, and may mean less time being treated and more time getting on with what matters to them.”

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.4

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.5 The overall safety profile of both medications was consistent with previously reported data.5 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.3

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.4

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.

Source

1. Burmester G et al. A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study). Ann Rheum Dis 2013; 0:1-6. doi:10.1136/annrheumdis-2013-203523.

2. Kivitz A et al. A Randomized, Double-Blind, Parallel-Group Study of the Safety and Efficacy of Tocilizumab Subcutaneous Versus Placebo in Combination With Traditional DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis (BREVACTA). ACR, November 2012.

3. Smolen J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 0:1-18. doi:10.1136/annrheumdis-2013-20457

4. RoACTEMRA Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Product_Information/human/000955/WC500054890.pdf (Last accessed March 2013).

5. Gabay C, et al. The Lancet 2013. 381;9877:1541-1550.

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