FDA Steps in to Manage Withdrawal of MS Drug Daclizumab (Zinbryta)

Susan Jeffrey

Disclosures

March 14, 2018

The US Food and Drug Administration (FDA) today announced it continues to work with manufacturers Biogen and AbbVie to manage withdrawal of the multiple sclerosis (MS) drug daclizumab (Zinbryta).

On March 2, as reported by Medscape Medical News, Biogen and AbbVie voluntarily pulled daclizumab for relapsing MS off the market worldwide because of mounting concerns about safety, including reports of severe liver damage and immune-related conditions.

"As a result, FDA is working closely with the manufacturers to help ensure a well-organized withdrawal from the market in the United States, and to ensure that health care professionals have the information they need to carefully transition their patients using Zinbryta to another treatment," the FDA said in a statement released today.

No new patients will start taking daclizumab or participate in clinical studies, the agency adds. "The company has begun notifying health care professionals and patients, and the drug will be available for patients as needed until April 30, 2018."

The statement warns that patients should not stop the medication without consulting their doctor "and should contact their doctor if they have any new and unexplained symptoms."

Questions or concerns about the withdrawal can be directed to the manufacturers' service center at 1-800-456-2255 or the manufacturer's website, the agency said.

"We understand that this may be a difficult situation for some patients and will continue to work closely with the manufacturers throughout the withdrawal process," the FDA said.

The "complex safety profile" of daclizumab has been recognized since the time of FDA approval, the statement notes.

"The drug's safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more multiple sclerosis drugs, to a boxed warning about the risk of liver injury and of other immune-mediated disorders, and to a Risk Evaluation and Mitigation Strategy making the drug only available through a restricted distribution program," the agency writes. "FDA has continuously monitored adverse events associated with use of Zinbryta and has updated product labeling as new information became available."

The company's announcement about the withdrawal on March 2 came the same day that the European Medicines Agency (EMA) announced an "urgent review" of daclizumab following seven cases of serious inflammatory brain disorders in Germany, including encephalitis and meningoencephalitis, and one case in Spain.

Subsequently, on March 7, the EMA recommended the immediate suspension and recall of daclizumab, following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis. Three of the cases were fatal.

In a statement at that time, the EMA said a preliminary review of the available evidence indicates that "immune reactions observed in the reported cases may be linked to the use of Zinbryta." It may also be linked to severe immune reactions affecting several other organs, the statement notes.

"To protect patients' health," EMA called for the immediate suspension of the drug's marketing authorization in the European Union and a recall of batches from pharmacies and hospitals.

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