Biogen’s Tecfidera Label Updated After Brain Infection Case
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The label for Biogen Idec Inc.’s multiple sclerosis drug Tecfidera will be updated with information about a patient who died of a rare brain infection while taking the medicine, U.S. regulators said today.
The drug label, which gives doctors and patients information about the drug, will now detail a case of progressive multifocal leukoencephalopathy, or PML, the Food and Drug Administration said. Biogen originally disclosed the patient’s death in October, while discussing third-quarter financial results.