Relapsing multiple sclerosis drug is removed from the market following reports of 8 cases of brain inflammation.
Biogen and AbbVie announced today the voluntary withdrawal of daclizumab (Zinbryta) for relapsing multiple sclerosis, after the European Medicines Agency’s (EMA) decision to start an urgent review following reports of 8 cases of inflammation of the brain.
The companies believe that due to the complexity of effects being reported, and the limited number of patients treated, characterizing the evolving benefit and risk profile of Zinbryta going forward is not possible.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” Alfred Sandrock, MD, PhD, executive vice president, chief medical officer, Biogen, said in a statement. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
The announcement to remove Zinbryta off the market comes the same day as the European Medicines Agency announced an urgent review initiating an Article 20 referral procedure following several cases of serious inflammatory brain disorders reported in Germany that included encephalitis and meningoencephalitis and 1 case in Spain.
Biogen was selling Zinbryta as a self-administered, once-monthly, under-the-skin injection for adults with relapsing forms of multiple sclerosis in the European Union, Switzerland, Canada and Australia, while AbbVie sold Zinbryta in the US.
It was approved by the US Food and Drug Administration (FDA) in May 2016 with a black box warning with the threat of liver toxicity. The EMA also advised against using Zinbryta in patients with preexisting hepatic disease or hepatic impairment and in those with autoimmune disease aside from multiple sclerosis.
Due to the risks, Zinbryta is generally used in populations that have not responded to 1 or 2 prior therapies. The safety and efficacy is unknown in children under 18 years of age.
Biogen continues to work with regulatory authorities and healthcare providers in the withdrawal of the product.
The Clinical Focus condition center at NeurologyLive, MD Magazine's new sister site, provides even more extensive coverage from the multiple sclerosis space, as well as updates from the field’s most prominent conferences.
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