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Tuesday, November 25, 2014

Biogen’s Tecfidera Label Updated After Rare Brain Infection Case

  Nov 25, 2014 

The label for Biogen Idec Inc. (BIIB)’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.
Tecfidera was Cambridge, Massachusetts-based Biogen’s top-selling drug in the third quarter, earning $787 million. Analysts said last month that the death wasn’t a cause for major concern, since 100,000 patients have already been treated with Tecfidera without developing PML.

The patient who died had a very low white blood cell count, which can weaken the immune system and increase the risk of PML, according to the FDA. The agency has recommended that physicians monitor Tecfidera patients’ white blood cell counts.

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