Zinbryta® Withdrawn from Marketplace
On March 2, 2018, Biogen and AbbVie announced the voluntary withdrawal of their MS medication, Zinbryta® (daclizumab), due to new safety concerns. Eight cases of inflammatory encephalitis and meningoencephalitis – both forms of brain inflammation – have been reported in two European countries. According to Reuters, seven cases of these serious brain disorders occurred in Germany and one case in Spain. Earlier issues with liver failure have also played a role in the decision to discontinue the marketing of this disease-modifying therapy (DMT) for multiple sclerosis (MS).
In a press release from Biogen and AbbVie, they state, “Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated. Therefore, Biogen and AbbVie believe it is in the best interest of the patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.” The press release also notes that Biogen will continue to work collaboratively with regulatory authorities and with healthcare providers in their management of individuals taking Zinbryta.
Anyone currently taking this medication should contact his or her healthcare provider as soon as possible to discuss discontinuing the medication and to learn about different treatment options for the future. When treatment is stopped, the effects of this medication continue at a decreasing rate for 8 to 12 weeks. For someone discontinuing Zinbryta, his or her physician will advise on the best time to begin another DMT for MS.
The United States Food and Drug Administration initially approved this DMT for the treatment of adults with relapsing forms of multiple sclerosis (MS) in May 2016. Zinbryta, a long-acting injection, was self-administered by the patient once monthly at his or her home, and was the only monoclonal antibody available by self-injection for the treatment of MS. Other monoclonal antibodies for the treatment of MS are given via intravenous (IV) infusion, usually at an infusion center or hospital. Zinbryta was approved as a therapy for individuals who previously experienced an inadequate response to at least two other MS treatments. The approval came with a black-box warning about potential serious liver damage.
For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.
Written by Susan Wells Courtney, MSAA Senior Writer
Reviewed by Dr. Jack Burks, MSAA Chief Medical Consultant