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Regulatory News | 02 March 2018 | By Michael Mezher
The European Medicines Agency (EMA) on Friday announced it is urgently reviewing Biogen and AbbVie's multiple sclerosis (MS) drug Zinbryta (daclizumab) after receiving seven reports of serious inflammatory brain disorders, known as inflammatory encephalitis and meningoencephalitis, in patients taking the drug in Germany and Spain.
In response to the safety concerns, Biogen and AbbVie said they will withdraw Zinbryta from the market worldwide. EMA also says that Biogen has informed the agency that it will stop its ongoing clinical studies for the drug in the EU.
"Given the nature and complexity of the adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated," the companies said in a statement, adding that Biogen will continue to work with regulators and healthcare providers to manage patients taking Zinbryta.
In its announcement, EMA said it will be contacting doctors throughout the EU with more detailed information, but in the meantime says that no new patients should start taking Zinbryta and that doctors should evaluate patients currently taking the drug and start them on an alternative therapy as soon as possible. EMA also advises patients not to stop taking Zinbryta before speaking with their doctors.
Zinbryta is currently marketed in the EU, US, Switzerland, Canada and Australia and was first approved by the US Food and Drug Administration (FDA) in May 2016 with a boxed warning for the risk of serious liver injury and immune conditions, and a risk evaluation and mitigation strategy (REMS) to restrict its distribution.
In statmenent to Focus, FDA spokesperson Jeremy Kahn said that FDA is aware of Biogen's decision to withdraw the drug from the US market and that the agency will work with the company on their withdrawal plan. EMA's announcement comes just seven months after the agency restricted the use of Zinbryta over liver safety concerns to only patients with highly active relapsing MS who have tried at least two other disease modifying treatments.
According to EMA, more than 8,000 patients have been treated with the drug in the EU, the bulk of which have been treated in Germany.
EMA, Biogen and AbbVie Statement