FDAnews Drug Daily Bulletin

EMA Updates Advice on Biogen Idec’s Tecfidera

Oct. 30, 2015

European regulators are advising doctors to perform a complete blood count on patients before and during treatment with Biogen Idec’s multiple sclerosis drug Tecfidera to minimize the risks of a rare brain infection.

A complete blood count should be performed every three months during treatment and a baseline MRI should be used as a reference usually within three months of starting therapy with Tecfidera (dimethyl fumarate), the European Medicines Agency says.

The new advice follows reports of three cases of progressive multifocal leukoencephalopathy in patients taking Tecfidera who had not received prior treatment with other drugs associated with the risk.

The EMA started reviewing the risk of PML in November 2014, following the first reported case. The FDA required a label warning about the link between Tecfidera and PML late last year.