German PEI limits use of daclizumab

Following a safety warning of the EMA on deaths related to Biogen’s multiple scleroisis (MS) drug Zinbryta (daclizumab), German regulatory authority has issued a red hand letter.


The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) launched a review of Biogen’s/AbbVie’s anti-CD25 antibody daclizumab (Zinbryta, Biogen/AbbVie), after a death from fulminant liver failure and  four cases of serious liver injury. The PRAC said in a statement it will evaluate all available data. The EMA is expected to decide on a renewal of the EU approval of the drug by September 2017. 

In a boxed warning letter, Germany’s Paul Ehrlich Institute said Daclizumab should not be used any longer in patients with liver disease or functional disorders of the liver or in patients with autoimmune co-morbidities. The agency said, the monoclonal antibody should not be used in combination with drugs that have known hepatotoxic effects. Additionally, the regulatory agency recommended to monitor liver blood markers during daclizumab therapy.

Daclizumab, given as a once-monthly injection, was first authorised for use in the European Union and received FDA approval later in 2016. The FDA had cautioned, that the daclizumab should only be used in patients who have failed to respond to one or two prior therapies, because it carries serious safety risks, including potentially severe liver damage and immune conditions.

Daclizumab selectively binds to the high-affinity interleukin-2 receptor subunit (CD25), which is expressed at abnormally high levels on T cells in patients with the relapsing/remitting form of MS.


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