Biogen and Elan resume Tysabri trials

Biogen and Elan have announced plans to resume trials of the Tysabri drug to treat multiple sclerosis (MS) after reviewing its performance.

The firms had been concerned at reports of progressive multifocal leukoencephalopathy, a rare and potentially fatal brain disease affecting the central nervous system and voluntarily suspended the drug from trials in the US market.

However, in a joint statement the companies said they were satisfied with the safety of the drug and have already enrolled and dosed the first patients in the monotherapy safety extension study program for treatment of MS.

“Patients who previously participated in the Phase III MS trials and subsequent safety evaluation are eligible to be screened for entry in this open label multi-centre study,” the statement read.

The deaths of two volunteers in the original trials brought about a postponement in the trial as further tests on the drug were completed, but Biogen and Elan say they are confident in the drug’s safety after a comprehensive evaluation process.

Trials will take place in the US, Europe, Canada, Australia, New Zealand and Israel in line with US Food and Drug Administration regulations and equivalent international protocols.

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