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Elan, Biogen Confirm 2nd Case of Disease
Posted on 2005-03-04 06:09:00
A second patient taking a recently suspended multiple sclerosis-fighting drug, Tysabri, has contracted a rare disease of the central nervous system, the Irish and American companies who developed the highly touted medication confirmed Friday. Elan Corp. of Ireland and Biogen Idec Inc. of Cambridge, Massachusetts, had announced Monday that they were withdrawing Tysabri because one patient had died of progressive multifocal leukoencephalopathy, a usually fatal disease, while a second patient was suspected of developing PML. The two companies said Friday that a second patient's suspected case of the disease had been confirmed, but he was still alive.
Tysabri had been approved in November by the U.S. Food and Drug Administration following promising clinical trials that demonstrated the drug's ability to prevent relapses in many MS sufferers. The drug was being used by about 3,000 MS sufferers in the U.S. and 22 people in Ireland before its withdrawal from the market. Tysabri was also withdrawn from clinical trials on sufferers of Crohn's disease and rheumatoid arthritis.
Both patients were taking Tysabri with Avonex, an older MS-fighting drug developed by Biogen Idec. It has remained on the market. The companies stressed in a joint statement that, for now, there was no evidence that either drug taken on its own was linked to PML. The companies also confirmed they both were providing unspecified new information to the U.S. Securities and Exchange Commission, which spent two years investigating accounting malpractice at Elan. The Irish company last month paid US$15 million (euro11.4 million) to the SEC to settle the probe.
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