A review of data concerning the multiple sclerosis (MS) medicine Zinbryta (daclizumab) confirmed its association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs, according to the European Medicines Agency‘s (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC).
Zinbryta was authorized in the global market in 2016 for the treatment of relapsing MS. Since then, 10,000 patients were treated worldwide with this medication. Within the European Union (EU), most of these patients were treated in Germany.
EMA stated that, based on preliminary data, 12 cases of inflammatory brain disorders worldwide were potentially related to the medication’s use. Cases of encephalitis and meningoencephalitis, or inflammation of the membranes enveloping the brain and spinal cord, resulted in three deaths.
Zinbryta’s review was initiated after a request from the European Commission on Feb. 26, under Article 20 of Regulation (EC) No 726/2004. The conclusion of the review is that Zinbryta’s risks outweigh its benefits.
There are no immediate consequences of the review since Zinbryta is no longer available in pharmacies and hospitals in the EU.
However, the EMA recommends that healthcare professionals continue monitoring patients who were treated with Zinbryta.
“Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected,” the EMA stated in a press release. “The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.”
This in line with previous recommendations from the EMA, suggesting that patients stopping treatment should be followed up for at least six months.
PRAC has now concluded its review on Zinbryta and will send it to the EMA’s Committee for Medicinal Products for Human Use (CHMP). Because the medicine is no longer authorized in the EU, no further action will be taken. The assessment report should be published soon.
Biogen and Abbie also are working closely with the U.S. Food and Drug Administration (FDA) for the withdrawal of Zinbryta in the U.S., according to Zinbryta’s website.
Patients taking Zinbryta are advised to contact their healthcare professionals and discuss a new treatment strategy.