The EC 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).
The approval was based on data from the Phase III SUMMACTA and BREVACTA trials; SUMMACTA showed that the efficacy and tolerability of subcutaneous RoACTEMRA was comparable with intravenous RoACTEMRA.
Furthermore, subcutaneous RoACTEMRA showed long-term efficacy and reduced progression of joint damage over 48 weeks compared to placebo in the BREVACTA trial.
The subcutaneous formulation of RoACTEMRA, which was approved in Japan and the US in 2013, will be available via a prefilled syringe.
The RoACTEMRA clinical development program included five Phase III clinical trials and enrolled over 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 for whom MTX treatment was considered ineffective or inappropriate.
The company said that 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.