Multimillion-dollar drug yanked from market connected to dangerous brain inflammation cases in U.S.

The Food and Drug Administration is reviewing whether a type of brain inflammation called encephalitis linked to Biogen Inc. and AbbVie Inc.’s multiple sclerosis drug Zinbryta was a result of a known side effect of the therapy or has another cause, a FDA spokesperson told MarketWatch.

Three U.S. cases of encephalitis related to Zinbryta have been reported in the U.S., though most cases have been reported in Europe, FDA spokesperson Sandy Walsh said. Encephalitis can lead to permanent disability and death.

Immune-mediated disorders, which can cause encephalitis, are known side effects of Zinbryta and the product’s U.S. label includes a warning.

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