March 02, 2018
Biogen and AbbVie are voluntarily taking daclizumab (Zinbryta) for relapsing multiple sclerosis (MS) off the market worldwide because of mounting concerns about safety, including reports of severe liver damage and immune-related conditions, the companies announced today.
Their announcement comes the same day that the European Medicines Agency (EMA) announced an "urgent review" of daclizumab after seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.
Given the nature and complexity of adverse events being reported, and the limited number of patients being treated, characterizing the evolving benefit/risk profile of daclizumab will not be possible going forward, Biogen and AbbVie said in a press statement.
Therefore, the voluntary worldwide withdrawal of the drug "is in the best interest of patients," Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in the statement.
Daclizumab, given as a once-monthly injection for adults with relapsing forms of MS, is currently available in the European Union, United States, Switzerland, Canada, and Australia.
Daclizumab was approved by the US Food and Drug Administration (FDA) in May 2016.
The FDA cautioned, however, that daclizumab should be used only in patients who have not responded to one or two prior therapies because it carries serious safety risks, including potentially severe liver damage and immune conditions.
Daclizumab was cleared for use in the European Union in July 2016. However, in June 2017, the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) launched a review of daclizumab after the death, from fulminant liver failure, of a patient who was treated with the drug in an ongoing observational study, as well as four cases of serious liver injury.
In July 2017, the EMA restricted use of daclizumab to patients who experience highly active relapsing MS despite having undergone a full and adequate course of treatment with at least one disease-modifying therapy (DMT) or patients with rapidly evolving severe relapsing MS who are unsuitable for treatment with other DMTs.
The EMA also advised against using daclizumab in patients with preexisting hepatic disease or hepatic impairment and in patients with autoimmune diseases other than MS.
PRAC recommended further restrictions on daclizumab in October 2017.
Biogen and AbbVie said they will continue to work collaboratively with regulatory authorities in the withdrawal of daclizumab and with healthcare providers who have patients using the drug.