CHMP recommends subcutaneous RoActemra for RA-Roche

The subcutaneous formulation of RoActemra (tocilizumab), from Roche, has received a positive opinion from the CHMP for the treatment of moderate to severe active Rheumatoid Arthritis (RA) in 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) inhibitors. As with the intravenous (IV) formulation indication, the CHMP has recommended approval of the subcutaneous formulation for use both as monotherapy and in combination with methotrexate (MTX).

The assessment is based on data from the Phase III SUMMACTA and BREVACTA studies. SUMMACTA showed that the efficacy and tolerability of subcutaneous RoActemra was comparable with IV RoActemra. Upon approval, RoActemra would be the first humanized interleukin-6 (IL-6) receptor-antagonist biologic in subcutaneous and intravenous formulation for both monotherapy and combination therapy. The subcutaneous formulation was authorized in Japan and the US earlier this year, where it is known as Actemra.