Zinbrynta Now Connected To Brain Inflammation

(RTTNews) - The Food and Drug Administration is reviewing whether Biogen Inc. and AbbVie Inc.'s multiple sclerosis drug Zinbryta is related to a type of brain inflammation called encephalitis.

The FDA is checking whether it is a result of known side effects of the therapy or have another cause, a FDA spokesperson told MarketWatch.

Three U.S. cases of encephalitis related to Zinbryta have been reported in the U.S., while many other cases have been reported in Europe, FDA spokesperson Sandy Walsh said, according to the report.

Immune-mediated disorders, which can cause encephalitis, are known side effects of Zinbryta and warned about on the product's U.S. label. However, the FDA is reviewing whether immune-mediated disorders or something else caused the reports of encephalitis.

Biogen and AbbVie withdrew the drug from global market, after the European Medicines Agency (EMA) started an urgent review of the drug.

EMA recommended the immediate suspension and recall of Zinbryta, following 12 reports of encephalitis, including three fatal cases.

"A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta. Zinbryta may also be linked to severe immune reactions affecting several other organs," the EMA said.

"EMA's recommendation to suspend Zinbryta and recall the product is being sent to the European Commission for a legally binding decision," it said.

Zinbryta was approved in 2016 for treating relapsing forms of multiple sclerosis. Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments. To date over 8,000 patients have been treated with Zinbryta worldwide.