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FDA Reviews MS Drug Tysabri



March 8, 2006

Multiple sclerosis patients pleaded with the Food and Drug Administration advisory panel on Tuesday to bring back the promising MS drug Tysabri, while the family of a women who died using the drug warned of it's dangerous side effects.

Tysabri was taken off the market in February 2005, only four months after its release, when three patients in clinical trials developed a fatal brain infection called progressive multifocal leukoencephalopathy (PML). Anita Smith and another patient died from the infection.

Now Tysabri's manufacturers, Biogen Idec Inc. and Elan Corp., are asking the FDA to allow the drug back on the market with limitations to its use. A drug recall reversal is rare and has only occurred one other time with the irritable bowel syndrome prescription drug Lotronex.

Anita Smith's family told the panel that she should never have been involved in the Tysabri clinical trials because her form of MS was mild. "We were never told Tysabri could result in Anita's death. If we had know that, we would have happily stayed away from the trial," said Beth Ann Smith, reading a statement for Anita's father.

Multiple sclerosis, a disease of the nervous system that results in permanent disability, affects 300,000 Americans. Studies have shown that Tysabri is twice as effective as other available MS drugs preventing relapse and delaying the worsening of the disease.

"The two-thirds reduction in relapse rate cannot be ignored. It is a striking result," said neurologist Dr. Richard Rudick, who spoke at the panel on behalf of Biogen.

Dozens of MS patients who testified at the advisory meeting told the FDA they should be allowed to make their own decision as to whether or not to take Tysabri.

"Life is all about trade-offs," said MS patient Barbara Crooks. "I am at the end of my road, in terms of what I can take. I want it to be my choice."

According to Dr. Russell Katz, director of the FDA's Division of Neurology Products, if Tysabri sales resume, about one in 1,000 patients may contract PML, which is not easily diagnosed and has no cure. In addition, FDA analysis reveals that Tysabri use may also be linked to other types of infection.

But many MS patients at the meeting were willing to take the risks. "There is one in 1,000 chance of developing MS. After winning that lottery, I am fully willing to become one of the 999 who don't develop PML while taking Tysabri," Ms patient Charlie Richardson said.

The FDA's health advisory panel will continue to review studies concerning the risks and benefits of Tysabri as well as listen to testimony from MS patients and health experts. The panel is expected to make their decision late Wednesday after two days of evaluation and discussion.

For more information on tysabri, please contact us to confer with an attorney.

 

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