Roche Submits sBLA to FDA for ACTEMRA
Roche has submitted a supplemental Biologics License Application (sBLA) to the FDA for ACTEMRA (tocilizumab, RoACTEMRA in the European Union) for the prevention of structural joint damage and to improve physical function in adults with moderately to severe active rheumatoid arthritis (RA).
ACTEMRA was approved by the FDA on January 8, 2010 as the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody to treat RA in adult patients after an inadequate response to at least one other medicine called a tumor necrosis factor (TNF) antagonist. RoACTEMRA was approved in the European Union in January 2009 for the treatment of RA in patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or TNF inhibitors. In September 2009 Roche submitted a filing to the European health authorities (the European Medicines Agency) to extend the indication of RoACTEMRA to inhibit the progression of joint damage and to improve physical function in patients with RA.
The US FDA application is based on positive results from the phase III LITHE1 trial which showed that patients receiving ACTEMRA in combination with methotrexate (MTX) had significantly less damage to their joints at two years, compared to patients who received MTX alone. The outcome was determined by x-rays which measured over time the progression of bone erosions and narrowing of joint spaces. The data showed that with long-term use, patients with rheumatoid arthritis treated with ACTEMRA 8mg/kg plus MTX suffered 81% less damage to their joints compared to those treated in the control group at Week 104.
The LITHE study also showed that patients who received either dose of ACTEMRA plus methotrexate showed significant improvement in physical function, compared with patients who received methotrexate plus placebo at Weeks 52 and 104, as measured by the mean area under the curve (AUC) of the Health Assessment Questionnaire Disability Index (HAQ-DI)i change from baseline.
“These data suggest that in addition to reducing the painful signs and symptoms of RA, ACTEMRA inhibits the progression of the disease by reducing long-term joint damage and improves physical function which are important goals of treating this chronic, debilitating disease,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.