On July 29, 2008, the Arthritis Advisory Board of the FDA reviewed the new Biologics License Application for tocilizumab, which will be marketed under the trade name Actemra, as presented by the manufacturer, Hoffmann-La Roche. After reviewing the efficacy and safety data from multiple Phase III studies, the Board recommended the approval of the biologic with a vote of 10 to 1. The FDA typically approves agents recommended by its advisory boards.
As discussed at the review, some safety issues remain to be clarified in post-marketing. These include the long-term safety effects of liver function, hematologic, and lipid abnormalities, as well as the occurrence of gastrointestinal perforation, which, though a rare, was observed more often in tocilizumab treated patients compared to those who received placebo.
