Biogen and Elan get approval to restart Tysabri trial

Controversial multiple sclerosis (MS) drug Tysabri has been approved for clinical testing by the US Food and Drug Administration (FDA).

Irish-based Elan and US firm Biogen announced that the agency had removed the hold of testing the drug, and will begin an open-label safety extension trial of the drug soon. Trials will be open to patients who participated in the phase III phase of the treatment’s testing.

Tysabri was removed from sale a year ago after three patients, treated with Tysabri, developed progressive multifocal leukoencephalopathy (PML) ? a potentially fatal viral disease which affects the brain. Two of the patients died.

Biogen and Elan claimed that a following safety evaluation of 3,000 Tysabri patients found no fresh cases of PML. It stated that it expects the drug to be assessed by the FDA’s peripheral and central nervous system advisory committee during March.

However, co-inventor Lawrence Steinman and Annette Langer-Gould, a fellow Stanford University neurologist, have called for the rules on testing the drug to be tightened and claimed that one of the PML victims did not have MS, the Los Angeles Times reported.

“We are concerned that not only were patients put at risk by Tysabri, but we feel that the risk was absolutely unnecessary to assume,” they said in an email to the FDA.

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