Roche receives EU approval for new subcutaneous formulation of RoACTEMRA providing more treatment flexibility for patients with moderate to severe rheumatoid arthritis

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the subcutaneous formulation of RoACTEMRA (tocilizumab) has received approval from the European Commission for the 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 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.

References

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.