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Roche Holding AG receives EU approval for new subcutaneous formulation of RoACTEMRA

Sunday, 27 Apr 2014 08:00pm EDT 

Roche Holding AG:Announces that subcutaneous formulation of RoACTEMRA (tocilizumab) has received approval from European Commission for 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 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 number of patients who have access to RoACTEMRA.Approval was based on data from phase III SUMMACTA and BREVACTA studies.SUMMACTA showed that efficacy and tolerability of subcutaneous RoACTEMRA was comparable with intravenous RoACTEMRA.In addition, subcutaneous RoACTEMRA demonstrated long-term efficacy and reduced progression of joint damage over 48 weeks compared to placebo in the BREVACTA study.Subcutaneous formulation of RoACTEMRA to be available via prefilled syringe.It was approved in Japan and United States in 2013. 

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-18.3 -6.34%
19 Dec 2014