Biogen Idec renounces marketing authorisation of the medicinal product Zinbryta (Daclizumab) for the treatment of patients with multiple sclerosis

This decision is based on reports on encephalitis/encephalopathy after administrating Zinbryta

Update 08.03.2018: EMA recommends immediate recall of the multiple sclerosis medicine Zinbryta (Daclizumab)

Information as of 02.13.2018:

Following the discussion with the Paul-Ehrlich-Institut (PEI) and the European Medicines Agency (EMA), Biogen Idec Ltd., the marketing authorisation holder of the medicinal product Zinbryta, renounced the marketing authorisation of this product at its own discretion after it became known that seven patients from Germany and one patient from Spain, who had been treated against multiple sclerosis with Zinbryta, had developed immune-mediated encephalitis/encephalopathy.

The marketing authorisation holder also indicated to stop the ongoing clinical studies and to initiate a recall of the batches of the medicinal product Zinbryta in Germany, immediately.

The PEI and the EMA recommend:

• that doctors refrain from treating new patients with Zinbryta,
• and that they contact their patients being treated with Zinbryta as soon as possible to discontinue this treatment and discuss alternative treatment options.
• In accordance with the summary of product characteristics (SOP), patients discontinuing the treatment with Zinbryta should remain under medical observation due to the product’s long half-life period.
• For further questions, patients are requested to contact their treating doctor.

The treating medical health care professionals will receive detailed information from the marketing authorisation holder shortly.

In addition, the EMA has started an urgent evaluation procedure of the medicine.

About Zinbryta

Zinbryta is a medicinal product (humanised monoclonal anti-CD25 antibody) authorised by the European Commission for the treatment of relapsing multiple sclerosis. After an evaluation procedure by the EMA because of life-threatening cases of liver inflammations (autoimmune hepatitis), the marketing authorisation for Zinbryta had already been restricted as early as 2017 to adult patients with relapsing multiple sclerosis who had not sufficiently responded to at least two disease-modifying therapies (DMT), and for whom treatment with any other DMT was contraindicated or unsuitable for other reasons.