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March 5, 2018

Biogen and AbbVie voluntarily withdraw Zinbryta authorisations

Biogen and AbbVie have voluntarily withdrawn the worldwide marketing authorisations for Zinbryta (daclizumab) for the treatment of relapsing multiple sclerosis (MS).

Biogen and AbbVie have voluntarily withdrawn the worldwide marketing authorisations for Zinbryta (daclizumab) for the treatment of relapsing multiple sclerosis (MS).

The move comes after the European Medicines Agency (EMA) called for an urgent review of the drug following reports of inflammatory encephalitis and meningoencephalitis, with seven cases reported in Germany and one in Spain.

In a statement, the companies said that the nature and complexity of the reported adverse events and the limited number of patients being treated make it difficult to determine the evolving benefit/risk profile of Zinbryta.

“Biogen believes the voluntary worldwide withdrawal of Zinbryta is in the best interest of patients.”

Executive vice-president and chief medical officer at Biogen Alfred Sandrock said: “Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients.

“Biogen and AbbVie continue to prioritise patient safety and the care of multiple sclerosis patients worldwide.”

The company said it would work with regulatory authorities on the withdrawal of the product and with healthcare providers to support Zinbryta patients.

According to the EMA, Biogen has also decided to cease all ongoing clinical trials involving Zinbryta in the European Union (EU).

Currently available in the EU, the US, Switzerland, Canada and Australia, Zinbryta is a prescription medicine indicated for adults with relapsing forms of MS.

After a review in 2017 of Zinbryta’s effect on the liver, the use of the drug has been restricted to patients for whom two or more MS medications have not worked.

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