Jan. 11, 2010 -- The FDA has approved Actemra for moderate to severe rheumatoid arthritis for patients who have not responded to one or more TNF inhibitors.
Actemra, given by once-monthly hour-long infusions, is the first IL-6 inhibitor for arthritis. TNF inhibitors include Cimzia, Enbrel, Humira, Remicade, and Simponi.
Actemra cannot be given in combination with these or other biologic treatments for arthritis. It can be used in combination with disease-modifying drugs such as methotrexate.
Although the drug is approved only for relatively severe disease, Roche says it's working with the FDA to extend approval to patients with earlier stages of rheumatoid arthritis (RA).
"We are optimistic that working with the agency, we will be able to generate the additional data required to support approval in earlier lines of RA therapy," Roche Chief Medical Officer Hal Barron, MD, says in a news release.
IL-6, or interleukin-6, is a chemical messenger involved in the destructive immune responses at the heart of arthritis. Arthritis patients have increased IL-6 levels.
In 2008, an FDA advisory panel voted 10-1 in favor of approving Actemra, also known by the generic name tocilizumab. It's already approved in Japan, Australia, and Europe, where it's sold as RoActemra.
Actemra was created by Genentech, now a part of drug giant Roche. In extensive clinical trials, Actemra was effective in reducing arthritis symptoms in patients in whom TNF inhibitors had failed.
Significant side effects in these clinical trials included serious infections, diverticulitis, and severe allergic reactions. Some patients had increased levels of cholesterol and blood fats.
Roche has agreed to an extensive post-marketing safety study and will support an active program to monitor patients taking the drug.
Actemra will be available to U.S. patients the week of Jan. 18, Roche says.