SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration has approved a Genentech drug for treating rheumatoid arthritis, the Roche subsidiary announced Friday.
The FDA approved Actemra (tocilizumab) for treating moderately to severely active rheumatoid arthritis in adults who have not responded adequately to tumor necrosis factor therapies. The drug is designed to be used alone or with disease modifying anti-rheumatic drugs such as methotrexate.
“The FDA approval of Actemra marks a major step forward in the treatment of RA, providing a new option for patients with this very serious disease,” Roche and Genentech EVP global development and chief medical officer Hal Barron stated. “We are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy and are committed to comprehensively characterizing both the clinical benefit and the safety of Actemra in earlier lines of therapy through our large pharmacovigilance program, including the risk management program, and ongoing clinical and post-marketing studies globally.”