Previous FDA Alert: [issued 2/2006]
The FDA has lifted the clinical hold on
Biogen-IDEC’s trials of natalizumab for patients with multiple
sclerosis (MS). Biogen-IDEC can now resume administration of
natalizumab to patients with relapsing-remitting MS who had
previously been treated with the drug in clinical trials.
Biogen-IDEC had previously suspended marketing of natalizumab
and all further dosing of patients in on-going clinical trials.
This decision was made after confirmation of one fatal case and
one additional case of severely disabling progressive
multifocal leukoencephalopathy (PML) in patients receiving
natalizumab for MS. A third case of PML, this one fatal, in a
patient with Crohn’s Disease had been identified shortly
thereafter.
