Pharmaceutical

FDA assists in Zinbryta MS drug’s removal from U.S. market

recalls Shutterstock 347x210 FDA assists in Zinbryta MS drugs removal from U.S. marketA week after drug makers Biogen and AbbVie announced they were pulling the multiple sclerosis (MS) drug Zinbryta from markets worldwide because the medication had been linked to severe liver damage and brain inflammation, the Food and Drug Administration (FDA) announced it planned to assist the drug companies with the management of the withdrawal in the U.S.

Zinbryta, known chemically as daclizumab, was approved to treat relapsing MS in the European Union, the United States, Switzerland, Canada, and Australia. Most of the 8,000-plus people treated with Zinbryta live in Germany.

The companies announced the withdrawal of Zinbryta after receiving eight reports of encephalitis and/or meningoencephalitis, both of which are brain inflammations. The cases were reported in seven patients in Germany and one in Spain. Biogen and AbbVie announced the drug’s withdrawal on the same day the European Medicines Agency said it would conduct an “urgent review” of the drug due to the reports of serious brain inflammation.

Zinbryta was approved in the U.S. in 2016 under the condition that it carry warnings that use could cause serious or life-threatening liver damage and serious immune system disorders. The agency also restricted the medication for patients who had tried at least two other disease-modifying treatments and were unable to be on any other multiple sclerosis drugs.

The FDA said it is working closely with manufacturers of the drug to ensure an organized withdrawal from the U.S. market, and to ensure health care professionals have the information they need to carefully transition patients taking the medication to another treatment.

As a result of the removal of Zinbryta, no new patients will start taking the drug or participate in clinical trials involving it. The companies have notified health care professionals of Zinbryta removal and that the medication will be available for patients through April 30, 2018, as needed.

Sources:
Medscape
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