Biogen, Elan announce FDA lifts hold on Tysabri trial for MS

By Lisa Kerner

Erie, Pa., Feb. 15 - Biogen Idec and Elan Corp. plc said they have been informed by the Food and Drug Administration that it has removed the hold on clinical trial dosing of Tysabri (natalizumab) in multiple sclerosis in the United States.

As a result, Biogen and Elan expect to begin an open-label, multi-center safety extension study of Tysabri monotherapy in the United States and internationally in the coming weeks, according to a company news release.

Patients who previously participated in the phase 3 MS program are eligible for entry.

The companies voluntarily suspended Tysabri from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy, a rare and potentially fatal disease of the central nervous system, the release stated.

The results of a safety evaluation of more than 3,000 Tysabri patients yielded no new confirmed cases beyond the three previously reported, the companies said.

On Sept. 26, Biogen and Elan announced they submitted a supplemental Biologics License Application to the FDA, and as a result, Tysabri was designated for priority review. The companies anticipate FDA action by late March.

Biogen develops, manufactures and commercializes therapies for oncology, neurology and immunology. The company is located in Cambridge, Mass.

Elan is a neuroscience-based biotechnology company with headquarters in Dublin, Ireland.

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