By Xinhua
Beijing : The U.S. Food and Drug Administration (FDA) approved Tysabri on Monday for use in patients with severe Crohn’s disease, media reported Tuesday.
Tysabri, jointly made by Elan Corp. and Biogen Idec Corp., was previously approved by FDA in 2004 as a treatment for multiple sclerosis but was pulled from the market in 2005 after a report that three patients in clinical trials contracted a brain infection known as progressive multifocal leukoencephalopathy and two patients died.
In 2006, FDA allowed the drug back on the market, but only under a restricted distribution program.
The FDA approved Tysabri for adults with moderate to severe Crohn’s disease who have evidence of inflammation and have a poor response to, or cannot take, other therapies.
Tysabri is an “important step” in treating Crohn’s but it carries serious risks, said Dr. Joyce Korvick, deputy director of the FDA division.
The companies were required to put similar limits as that for multiple sclerosis patients on sales for Crohn’s disease.
Meanwhile, Crohn’s disease patients must undergo an educational program on the drug’s risks and can only receive the injectable drug from a select number of registered physicians.
Tysabri will be available to Crohn’s patients by the end of February, Elan said in a statement.