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Regulatory News | 07 July 2017 | By Zachary Brennan
The European Medicines Agency (EMA) on Friday announced it is provisionally restricting the use of Biogen Idec’s multiple sclerosis (MS) medicine Zinbryta (daclizumab) to patients with highly active relapsing disease that have failed to respond to other drugs, and to patients with rapidly evolving relapsing disease who cannot be treated with other medicines.
In addition, EMA said, "patients with liver injury must not be given the medicine. Starting treatment with Zinbryta is not recommended for patients with autoimmune diseases other than multiple sclerosis and caution should be used when giving Zinbryta together with medicines that can damage the liver."
Doctors should continue to monitor the liver function of patients receiving the medicine and closely watch patients for signs and symptoms of liver injury, EMA said, adding, "These are provisional recommendations that EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued, as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing."
Initially authorized in the EU in July 2016 and in the US in May 2016, Zinbryta is used to treat adults with relapsing forms of MS. EMA’s review of Zinbryta began after a death from liver injury during an ongoing observational study, as well as four cases of serious liver injury.
FDA's boxed warning for the drug tells prescribers that it can cause severe liver injury, including life-threatening and fatal events.
The EU review was initiated at the request of the European Commission (EC) and while it is ongoing, the PRAC made its provisional recommendations. These will now be forwarded to the EC, which will issue a provisional legally binding decision applicable in all EU member states.
"Healthcare professionals will be informed in writing about the provisional measures to be followed by doctors. Once the review is concluded, EMA will communicate further and provide updated guidance to patients and healthcare professionals," EMA said.
EMA Press Release
Tags: Biogen, MS, EMA PRAC