The relapsing multiple sclerosis treatment Zinbryta (daclizumab beta) has been recommended for immediate suspension and withdrawal from the market by the European Medicines Agency (EMA).
The decision follows 12 reports worldwide of severe immune-mediated brain inflammation in patients taking the drug, three of which were fatal. The drug has also been linked to severe liver damage and immune-mediated disorders.
The EMA announcement means patients currently receiving Zinbryta should have their treatment stopped as soon as possible and be monitored for at least six months, and no new patients should start taking the drug.
The manufacturer Biogen had already requested the EMA withdraw the product’s marketing authorisation and notified them of their intention to cease all clinical trials of the drug. On 2 March 2018, the EMA announced it was launching an urgent review into Zinbryta and has said it will be publishing in-depth findings.
The charity MS-UK said the drug, which received its European marketing authorisation in July 2016, is being used by fewer than 100 patients in the UK.