Roche Holding AG said U.S. regulators have widened the approved use of rheumatoid arthritis drug Actemra to include patients typically in earlier stages of treatment for the joint disease.
Actemra was approved in early 2010 for patients who had failed treatment with a widely used class of medicines called TNF inhibitors, which include Abbott Laboratories Inc's Humira and Embrel 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.
(Reporting by Ransdell Pierson and Bill Berkrot in New York; editing by Matthew Lewis)