by Judy George, Contributing Writer, MedPage Today
Biogen and Abbvie voluntarily pulled the multiple sclerosis drug daclizumab (Zinbryta) from the worldwide market today, following reports of inflammatory encephalitis and meningoencephalitis in patients in Europe.
The European Medicines Agency (EMA) started an urgent review of the drug after seven cases of serious inflammatory brain disorders in Germany — including encephalitis and meningoencephalitis — and one case in Spain were reported.
Daclizumab is a self-administered, under-the-skin injection for relapsing forms of multiple sclerosis. In the United States, the FDA approved the drug in 2016 with a boxed warning that the product could cause severe liver injury, including life-threatening and fatal events. These risks prompted the FDA to caution that daclizumab should be used only in patients who had failed to respond to one or two prior therapies.
The drug targets the α-chain of the interleukin-2 receptor CD25. In the phase III DECIDE trial, daclizumab reduced relapse rates and disability progression more effectively than interferon beta-1a (Avonex), but the liver toxicity that had been seen in earlier studies remained a problem. In the phase II SELECTION trial, one patient died from autoimmune hepatitis and two others developed autoimmune conditions affecting vital organs.
“This news is not surprising,” Mark Freedman, MD, of the University of Ottawa, told MedPage Today. “There are so many other better drugs available that many of us had a hard time positioning it in our MS armamentarium.”
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