March 7 (Reuters) - Europe's medicines regulator recommendedthe immediate suspension and recall of Biogen Inc BIIB.O andAbbVie Inc's ABBV.N multiple sclerosis drug Zinbryta,following 12 reports of inflammation of the brain, three ofwhich cases were fatal.
Biogen and AbbVie withdrew the drug last week, after theEuropean Medicines Agency (EMA) started an urgent review. preliminary review of the available evidence indicatesthat immune reactions observed in the reported cases may belinked to the use of Zinbryta. Zinbryta may also be linked tosevere immune reactions affecting several other organs," the EMAsaid on Wednesday. regulator added that it was recommending the immediatesuspension of the medicine's marketing authorisation in theEuropean Union and a recall of batches from pharmacies andhospitals.
"EMA's recommendation to suspend Zinbryta and recall theproduct is being sent to the European Commission for a legallybinding decision," it said.
Zinbryta was approved by U.S. regulators in 2016 with awarning on the packaging due to risks of liver damage, withBiogen selling the self-administered drug in Switzerland, Canadaand the EU and AbbVie in the United States.
In November, the European regulator flagged safety concernsabout the drug, restricting its usage to reduce the risk ofserious liver damage.
The drug, which has been used to treat over 8,000 patientsso far, brought in worldwide sales of $107 million last year,with Biogen's share being $53 million. became part of the U.S. political debate over highdrug costs in September, when Democratic Congressman ElijahCummings asked the government to take action on the drug's$87,000 price tag.