The European Commission (EC) has approved Roche’s subcutaneous formulation of RoACTEMRA (tocilizumab) to treat moderate to severe rheumatoid arthritis (RA) in patients who are either intolerant to or have failed to respond to other RA treatments.
The 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).
Roche head of global product development and chief medical officer Sandra Horning said the European approval of RoActemra provides physicians and patients with the flexibility to choose a treatment method that suits their needs.
"Together with their physicians, patients can choose whether to self-inject RoACTEMRA at home or have it administered in their doctor’s office," Horning said.
EC approval was based on data secured from the Phase III SUMMACTA and BREVACTA trials.
The SUMMACTA trial showed that efficacy and tolerability of subcutaneous RoACTEMRA was comparable with intravenous RoACTEMRA.
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In addition, subcutaneous RoACTEMRA showed long-term efficacy and reduced progression of joint damage over 48 weeks compared with placebo in the BREVACTA trial.
The company said that the subcutaneous formulation of RoACTEMRA will be available via a prefilled syringe, which was previously approved in Japan and the US in 2013.
RoACTEMRA is indicated to treat moderate to severe RA in adult patients who have either responded inadequately to, or who are intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
The RoACTEMRA clinical development programme included five Phase III clinical trials and enrolled more than 4,000 people with RA in 41 countries.
In addition, the Phase IV ADACTA trial 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 where MTX treatment was considered ineffective or inappropriate.
Intravenous formulation of RoACTEMRA 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.
Image: X-ray of the hand in rheumatoid arthritis. Photo: courtesy of Braegel.