FDA OKs Use of Actemra for Earlier-Stage Arthritis Treatment

October 15, 2012

(Reuters) Oct 12 - Roche Holding AG said U.S. regulators have widened the approved use of rheumatoid arthritis drug Actemra (tocilizumab injection) to include patients typically in earlier stages of treatment for the joint disease.

Actemra was approved in early 2010 for patients with moderately to severely active RA who have had an inadequate response to a TNF inhibitor such as Abbott Laboratories Inc's Humira (adalimumab) and Enbrel (etanercept) from Amgen Inc and Pfizer Inc.

But Roche's Genentech drug unit on Friday said the U.S. Food and Drug Administration is now allowing the company to market Actemra for patients who had failed to benefit from methotrexate or other drugs typically given prior to TNF inhibitors.

In effect, Actemra can now be used as a second-line therapy, instead of as a third treatment option.