FDA permits Biogen, Elan to add anti-JC virus status in Tysabri label
This article was originally published in Scrip
Executive Summary
Biogen Idec and its Irish partner Elan said the US FDA has permitted the firms to revise the labelling for Tysabri (natalizumab) to add anti-JC virus antibody status as a risk factor for developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, which can result in death.