ZINBRYTA® (daclizumab) VOLUNTARY WITHDRAWAL
Biogen, in collaboration with our partner AbbVie, voluntarily withdrew the marketing application for ZINBRYTA in the United States on April 30, 2018.
Biogen has recently completed a clinical assessment of encephalitis cases reported in patients treated with ZINBRYTA and concluded that immune-mediated encephalitis, including anti-NMDA receptor encephalitis, are adverse drug reactions that can be related to treatment with ZINBRYTA.
Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw ZINBRYTA in the United States. Given the nature and complexity of adverse events being reported with ZINBRYTA, characterizing the evolving benefit/risk profile of ZINBRYTA will not be possible going forward, given the limited number of patients being treated.
Patients that have not started a new treatment plan are advised to speak with their HCP as soon as possible.Click here to view the patient letter that Biogen has issued regarding the withdrawal and associated timing.
Patients are advised to speak with their HCPs regarding new or worsening of symptoms.
Health Care Professionals Click here to view the Dear Prescriber Letter that Biogen sent regarding the withdrawal and associated timing.
Click here to view the Dear Prescriber Letter that Biogen sent regarding immune-mediated encephalitis as an adverse drug reaction that can be related to treatment with ZINBRYTA.