Recall Requested for Biogen’s MS Drug
The European Medicines Agency (EMA) has recommended an immediate suspension and recall of Zinbryta, a multiple sclerosis drug from Biogen Inc. and AbbVie Inc. after the death of three patients. The drug was voluntarily suspended by Biogen last week when the EMA announced that they were launching an urgent review.
“A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta,” the EMA statement reads. “Zinbryta may also be linked to severe immune reactions affecting several other organs. To protect patients’ health, EMA is recommending the immediate suspension of the medicine‘s marketing authorisation in the EU and a recall of batches from pharmacies and hospitals.”
Zinbryta was approved for AbbVie in the US in 2016, with Biogen marketing the drug in Switzerland, Canada, and the European Union (EU). Since then, it has been used to treat over 8,000 patients and generated $107M (£77.1M) worldwide last year alone. When the drug was first brought to the market, it was labelled with a warning relating to possible liver damage for patients; then, in November 2017, the EMA raised safety concerns and limited use of the drug to prevent serious liver damage.
Now, the drug has been implicated in 12 cases of inflammatory brain disorders, including encephalitis and meningocephalitis, three of which resulted in the death of the patient. In response, the EMA is calling for the drug to be discontinued with immediate effect.
“No new patients should start treatment with Zinbryta,” the statement says. “Healthcare professionals should immediately contact patients currently being treated with Zinbryta and should stop their treatment and consider alternatives. Patients stopping treatment must be followed up for at least 6 months.”
The recall request will now be passed to the European Commission, who will be able to supply a legally binding decision.