The European Medicines Agency is now recommending the immediate suspension and recall of Biogen’s multiple sclerosis therapy Zinbryta, just days after announcing a safety review.
The regulator says it has received 12 reports of serious inflammatory brain disorders - including encephalitis and meningoencephalitis - in patients taking the drug, three of which were fatal.
A preliminary review of evidence indicates that immune reactions observed in the reported cases could be linked to the use of Zinbryta (daclizumab), and that the drug may be involved in severe immune reactions affecting several other organs.
As such, the EMA is recommending to the European Commission the immediate suspension of the medicine‘s marketing authorisation in the EU, as well as a recall of batches from pharmacies and hospitals, just days after starting its review.
In any case, Biogen and AbbVie have already said that they intend to voluntarily withdraw the medicine’s marketing authorisations around the globe, as well as suspend ongoing clinical studies.
Zinbryta was first approved in 2016 for treating relapsing forms of multiple sclerosis.
In 2017, the drug’s was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other MS treatments, following a review of its effects on the liver.
To date over 8,000 patients have been treated with Zinbryta around the globe, with the majority of EU patients treated in Germany.