Actemra Recommended for Approval
The Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) by a near unanimous vote (10-1) recommended approval of tocilizumab (Actemra), for reducing signs and symptoms in adults with moderate to severe rheumatoid arthritis (RA). If the FDA follows the committee’s recommendation, which is usually does, Actemra will become the seventh biologic agent approved for the treatment of RA.
The committee's vote was made after Roche, Actemra’s manufacturer, presented results from five Phase III clinical trials designed to evaluate the effects of Actemra on signs and symptoms of RA, physical function, progression of structural damage, and health-related quality of life. The trials enrolled more than 4,000 patients in 41 countries, including the United States.
Robert A Harrell, MD, a Durham, N.C., rheumatologist who was involved with the Actemra trials, says the new agent should be a valuable addition to the RA medications available now. “It works by a completely different mechanism than existing drugs and seems to give very impressive and rapid benefit,” he says. “Although this is not scientific, my study staff and I have have seen more dramatic responses to Actemra than any other investigational drug with which we have been involved.”
Actemra will be the first biologic agent approved that works by inhibiting the activity of IL-6, one of several key cytokines involved in the inflammatory process. Other biologics work by blocking other cytokines, including tumor necrosis factor-alpha (TNF-a), that ultimately lead to joint destruction in RA.
“I do not know which indications the FDA will approve, but I suspect its initial use will primarily be in RA patients who have failed anti-TNF therapy,” says Dr. Harrell.
While Actemra may have some advantages for certain people over current biologic agents, it does have some potential toxicity issues to be watched such as liver function test elevations, lipid elevations, white blood cell count reductions, and infections, says Dr. Harrell. The most common adverse events reported in clinical trials were upper respiratory tract infection, nasal congestion, headache and hypertension.
Read an Arthritis Today exclusive Q & A about Actemra.
Read an In the Pipeline article about Actemra.
Read more about biologic agents in Arthritis Today’s Drug Guide.
