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Amid concerns about reports of serious brain inflammation risks with Zinbryta, the effective multiple sclerosis drug was removed from the market last month, leading researchers to highlight that development of new drugs must be contingent on maintaining or improving on the risk-benefit profile of other available multiple sclerosis treatments.
Zinbryta (daclizumab) was an injection drug sold by Biogen and AbbVie, which was just introduced in 2016. The FDA has approved Zinbryta for the treatment of adult patients with relapsing forms of multiple sclerosis. Due to a risk of liver injury linked to Zinbryta side effects, the drug was made available subject to a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S., and regulators only recommended it as a treatment for individuals who have failed to respond to other first-line MS drugs.
Following reports of problems with Zinbryta brain inflammation, including cases of encephalitis and meningoecephalitis, the drug makers announced that they were voluntarily removing the drug from the market worldwide in March 2018.
In a report published in the Spanish medical journal Revista de Neurologia on April 16, researchers point out that Zibryta was show to be effective at slowing the inflammation process of multiple sclerosis. However problems with encephalitis, autoimmune issues and other adverse health effects meant it never seriously could have been a widespread MS drug, raising questions about the drug development and approval process.
Researchers conducted a “post-mortem” on the drug, noting that Zinbryta development started out as a possible leukemia therapy in the late 90s, but its immune suppressing abilities were later focused toward the treatment of MS. Even then, it showed a number of potential safety problems.
Production was temporarily stopped in 2009, but not due to the safety signals, but instead due to a perceived lack of profitability in the face of other alternative treatments. Recasting it as an MS drug gave it new life, but the safety problems persisted.
Francisco Carlos Perez Miralles, of Hospital Universitari i Politecnic La Fe, in Valencia, Spain, indicates in the report that Zinbryta was effective in preventing relapses, to the point that it was on part with first-line MS drugs.
“On the other hand, it presents safety problems that have meant that the different drug agencies imposed an important restriction on their use,” the report determines. “In any case, although the pharmacovigilance systems have acted quickly, a debate is opened on the bidding of new drugs in MS, especially in those with an unfavorable risk-benefit profile compared to those currently in use.”
Only about 8,000 individuals worldwide have used Zinbryta, highlighting the serious brain inflammation risks with at least 12 reports known to be linked to use of the drug.
At least three Zinbryta deaths have been reported, all of which occurred in the United States, which led the FDA to launch an investigation into the reports. The agency was reassessing the drug’s safety profile when European regulators and the manufacturers decided the drug should be pulled from the market.
Due to questions about whether the medication was adequately researched, and whether proper warnings were provided to consumers and the medical community, the potential for Zinbryta lawsuits are also being evaluated by some product liability lawyers.