Genentech submits ACTEMRA sBLA to FDA

Mar 17 2010

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA^® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely 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.

“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”

The application is based on positive results from the Phase III LITHE 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. In addition, 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 with MTX alone at Week 104 based on Total-Sharp Genant Score. Patients treated with 4 mg/kg plus MTX also had a statistically significant reduction in Total-Sharp Genant Score at Week 104 of therapy.

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) 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., head, Global Development and chief medical officer at Roche.