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ARTICLE | Company News

CHMP backs subcutaneous RoActemra

December 21, 2013 2:24 AM UTC

Roche (SIX:ROG; OTCQX:RHHBY) said EMA's CHMP recommended approval of a subcutaneous formulation of RoActemra tocilizumab as monotherapy or in combination with methotrexate to treat moderate to severe active rheumatoid arthritis (RA) in patients who have an inadequate response to or who are intolerant of DMARDs or TNF inhibitors. The subcutaneous formulation would be available for self-administration in a prefilled syringe and a prefilled pen. In October, FDA approved a BLA from Roche's Genentech Inc. unit for the subcutaneous formulation. ...