EC Approves Roche’s Roactemra against Active Systemic Juvenile Idiopathic Arthritis

Roche has won European approval for broader use of its arthritis drug RoActemra to treat children with a rare and severe form of the disease.

Swiss drugmaker Roche announced Wednesday that the European Commission has approved the use of RoACTEMRA (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (sJIA) in patients two years of age and older who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.

RoACTEMRA (known as ACTEMRA outside Europe) can be given alone or in combination with methotrexate in patients with sJIA.

"This approval in Europe is an important advance in the treatment of sJIA, a debilitating condition affecting children,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. “RoACTEMRA is the first and only biological treatment to demonstrate significant efficacy in this patient population an