Biogen, Elan resume Tysabri clinical trial

By Elaine Rigoli

Tampa, Fla., March 29 - Biogen Idec and Elan Corp. plc. have enrolled and dosed the first patients in the Tysabri (natalizumab) monotherapy safety extension study program in multiple sclerosis.

Patients who previously participated in the phase 3 trials and subsequent safety evaluation are eligible to be screened for entry in this open-label, multi-center study, according to a news release.

Sites throughout Europe, the United States, Canada, Australia, New Zealand and Israel are expected to enroll patients.

This safety extension study is being conducted under a Food and Drug Administration Investigational New Drug application in the United States and similar investigational approvals internationally.

Biogen Idec and Elan had previously voluntarily suspended Tysabri from the U.S. market and dosing in all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system.

The companies said they completed a comprehensive safety evaluation of more than 3,000 trial patients in collaboration with leading experts in PML and MS.

The results of the safety evaluation yielded no new confirmed cases of PML beyond the three previously reported, the release said.

The companies anticipate action by the FDA regarding the reintroduction of Tysabri in the United States by June 28.

The companies' application for approval of Tysabri as a treatment for MS is also under review with the European Medicines Agency, the release said.

Cambridge, Mass.-based Biogen develops products for oncology, neurology and immunology.

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

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