The pharmaceutical companies Biogen and AbbVie that market the disease-modifying therapy (DMT) Zinbryta recently announced that they were voluntarily withdrawing the treatment from all global markets.1 This decision took place after the European Medicines Agency (EMA), the regulatory authority in the European Union, began an “urgent review” of the medicine after eight cases of severe brain inflammation were discovered in patients in Europe. The EMA urged doctors to review their patients currently being treated with Zinbryta and switch them to an alternative treatment as soon as possible. In response, Biogen and AbbVie decided that withdrawing the medicine was in the best interest of patients living with MS.2
Zinbryta was approved by the FDA for relapsing multiple sclerosis in May 2017, but it did pose several safety risks, including severe liver injury and immune conditions. Due to the risks, the FDA stated that Zinbryta should only be used by patients for whom the use of two or more previous DMTs was unsuccessful. The drug was also only available through a restricted distribution program.
Patients who are currently using Zinbryta have been advised not to stop their medication without first consulting their doctor in order to safely transition to alternative treatment.
Dennis M. Biogen, AbbVie withdraw multiple sclerosis therapy Zinbryta from market. FirstWord Pharma. March 2, 2018. Accessed online March 5, 2018. Available from: https://www.firstwordpharma.com/node/1546123
Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for ZINBRYTA® (daclizumab) for Relapsing Multiple Sclerosis. Biogen. March 2, 2018. Accessed online March 5, 2018.