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Biogen, Elan Resume Trial of MS Drug

Posted on: Wednesday, 15 February 2006, 18:00 CST

Biogen Idec and Elan said Wednesday they are OK'd to resume study of multiple-sclerosis drug Tysabri.

The firms said the Food and Drug Administration has lifted its hold on dosing in the open label, multi-center safety extension study of Tysabri, being tested as a monotherapy for multiple sclerosis.

The companies said they have found no further cases of a rare central nervous system disorder in study patients that had prompted them to suspend the research.

Patients who previously took part in the phase 3 study are still eligible for enrollment in the continued trial, the companies said.

Biogen Idec and Dublin, Ireland-based Elan had halted the study following reports of a rare, sometimes fatal condition in three patients known as progressive multifocal leukoencephalopathy.

The development partners said they have completed a comprehensive safety evaluation of more than 3,000 patients taking Tysabri in collaboration with leading experts in PML and MS and did not identify additional cases of PML.

Biogen Idec and Elan said they filed for FDA approval of Tysabri in September 2005 and that the application was granted priority review, meaning the agency will complete its review of the application within six months.

Source: United Press International

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