FDA approves rheumatoid arthritis drug for adults

Sunday Jan 10, 2010 (foodconsumer.org) -- The Food and Drug Administration has approved Actemra for the treatment of rheumatoid arthritis (RA), biotechnology company Genentech, Inc. announced this week.

Actemra is indicated for the treatment of adult patients with moderately to severe RA who have had inadequate response to existing arthritis treatments.
"The FDA approval of Actemra marks a major step forward in the treatment of RA, providing a new option for patients with this very serious d isease," said Hal Barron, chief medical officer for Genentech and the parent company, the Roche Group, according to a company statement.

Rheumatoid arthritis is a chronic, progressive inflammatory disease of the joints and tissues resulting in intense pain, joint destruction and a variety of other complications.
The ailment is not the same as arthritis, according to WebMD, but is an auto-immune disease, meaning the body's immune system is mistakenly attacking the tissues it is supposed to protect.

Actemra blocks the effects of a protein, IL-6, which causes the inflammation of joints and tissues, according to study investigator Dr. Mark Genovese, Professor of Medicine at Stanford University Medical Center.

"For many RA patients, treatment with existing therapies does not resolve the painful and debilitating symptoms of the disease," said Genovese. "Data from the clinical development program clearly establish Actemra and its unique mechanism of action as an important new option for RA patients who experience continued disease symptoms despite treatment with existing therapies."

Actemra has been studied in five multi-national studies involving more than 4,000 participants, the largest clinical development program for RA to date, according to Genentech.

The drug has been approved for use in Japan, the European Union, India, Brazil, Switzerland and Australia.

Worldwide, it is estimated that 1 percent of the population has RA, with about 1.3 million people affected in the United States alone.  RA affects 5 to 6 percent of Native Americans, while people from the Caribbean or of African descent have very low incidence of the disease.

RA is most likely to strike people at the age of 35 to 50 years of age, but it can also occur in children, teenagers, and the elderly.

By Sheilah Downey