FDA expands approved indication for Genentech’s ACTEMRA to treat active rheumatoid arthritis

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved indication for ACTEMRA^® (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ACTEMRA can be used both alone as a single-agent therapy and in combination with methotrexate (MTX) or other DMARDs. The expanded indication further supports the safety and efficacy profile of ACTEMRA.

"People with moderately to severely active RA can suffer irreversible joint damage that may be prevented by earlier treatment with a biologic medicine such as ACTEMRA," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We're pleased that these patients will now have ACTEMRA as an additional option."

The expanded indication is based on efficacy and safety data from the Phase III clinical trials which were previously available, safety data collected from the post-marketing experience with ACTEMRA since approval in 2010, as well as data from other clinical studies, including those evaluating ACTEMRA in a real-world setting.

Source: Genentech, Inc.