The US Food and Drug Administration has expanded the approval of Actemra® (tocilizumab) to allow use of the drug earlier in the course of rheumatoid arthritis.
Rheumatoid arthritis (RA) affects an estimated 1.3 million adults in the United States. The good news is that important advances have been made in the management of RA: use of more effective drugs earlier in the course of RA reduces symptoms and joint damage and allows some patients to achieve a remission (little or no active disease).
Treatment of RA often begins with methotrexate or another disease-modifying antirheumatic drug (DMARD). If this initial treatment does not adequately control the RA, patients may move on to treatment with a newer, biologic DMARD.
Actemra is a biologic DMARD that blocks the action of a protein known as IL-6. IL-6 plays a role in inflammation and can contribute to the signs and symptoms of RA by prompting white blood cells to attack certain tissues in the body.
Originally, Actemra was approved for RA patients who had had an inadequate response to another type of biologic DMARD known as a TNF inhibitor. With the expanded approval, prior treatment with a TNF inhibitor is no longer required.
According to the expanded approval, Actemra is intended for adults with moderately to severely active RA who have had an inadequate response to at least one prior DMARD.
This decision by the FDA expands the treatment options available to patients with early RA.
Actemra is also used for the treatment of systemic juvenile idiopathic arthritis (SJIA).
Reference: Genentech press release. FDA approves expanded indication for Actemra in rheumatoid arthritis. October 12, 2012.