Genentech, Inc. , a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA? (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
ACTEMRA is the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat RA, and may be used alone or in combination with methotrexate or other disease modifying anti-rheumatic drugs (DMARDs).
“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,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche and Genentech.
“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.”
RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications. There are several key cytokines, or proteins, involved in the inflammatory process, including IL-6. Research shows that IL-6 levels are elevated in patients with RA. ACTEMRA is the first medication designed to specifically inhibit the biological activity of IL-6.
“For many RA patients, treatment with existing therapies does not resolve the painful and debilitating symptoms of the disease,” said Mark Genovese, M.D. , ACTEMRA study investigator and Professor of Medicine and Co-Chief of the Division of Immunology and Rheumatology at Stanford University Medical Center. “Data from the clinical development program clearly establish ACTEMRA and its unique mechanism of action as an important new option for RA patients who experience continued disease symptoms despite treatment with existing therapies. ”
ACTEMRA has been studied in five multi-national Phase III studies, involving more than 4,000 patients, making it the largest clinical development program for an indication in RA to date. The studies showed that ACTEMRA ? alone or in combination with methotrexate or other DMARDs ? significantly reduced RA signs and symptoms compared with DMARDs alone.
Source: Genentech, USA