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
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
IL-6, or interleukin-6, is a chemical messenger involved in the destructive
immune responses at the heart of arthritis. Arthritis patients have increased
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