Biogen, Abbvie pull MS drug from global market
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Due to concerns about the benefits and risks of Zinbryta, Biogen and Abbvie voluntarily withdrew the multiple sclerosis drug from the global market, according to a press release.
The FDA is collaborating with the manufacturers to ensure an efficient withdrawal from the United States market and to help health care providers to wane patients off Zinbryta (daclizumab, Biogen, Abbvie) and transition to another treatment, according to the release.
Daclizumab should not be prescribed to new patients and will only be available to current users until April 20, 2018, according to the release.
The drug is known to have a complex safety profile, which has been recognized by the FDA since its approval, according to the release. Its use has been mostly limited to patients who experience inadequate responses to two or more MS drugs, according to the release. Daclizumab also included a boxed warning on the risk for liver injury and other immune-mediated disorders, according to the release.
The drug was recently recalled by the European Medicines Agency after 12 cases of serious inflammatory brain disorders worldwide, according to the release. The FDA is currently reviewing the drug for similar events, according to the release.