Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG;
OTCQX: RHHBY), today 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”
"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. This approval is based on data from the following studies: