Biogen Inc. and AbbVie Inc. have taken the rare step of issuing a worldwide drug recall for Zinbryta, after the multiple sclerosis (MS) drug was tied to reports of encephalitis and other inflammatory brain disorders, some of which were fatal.
Zinbryta (daclizumab) was approved by the U.S. Food & Drug Administration (FDA) in May 2016. It is indicated for treatment of adults with relapsing forms of multiple sclerosis. The long-acting injection is self-administered monthly.
In approving Zinbryta, the FDA advised that it generally be prescribed only to patients who have had an inadequate response to two or more MS drugs. The caution reflected Zinbryta’s potential to cause serious side effects, including liver injury and immune disorders.
In addition to the United States, Zinbryta is sold in the European Union, Switzerland, Canada, and Australia. It is estimated that more than 8,000 patients have been treated with the medication.
The Zinbryta recall was recommended by the European Medicines Agency (EMA), following a dozen reports of serious brain inflammation, including encephalitis and/or meningoencephalitis, among patients treated with the drug.
“To protect patients’ health, EMA is recommending the immediate suspension of the medicine‘s marketing authorization in the EU and a recall of batches from pharmacies and hospitals,” the regulator said in a statement issued on March 7th.
Three Zinbryta patients in the United States have died due to encephalitis. The FDA is also reviewing the drug’s safety.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta….is in the best interest of patients,” Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen, said in a statement announcing the recall. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.
Biogen and AbbVie have indicated that Zinbryta patients should contact their healthcare providers for advice.
The EMA has advised patients to contact their doctor immediately if they have or experience any of the following symptoms:
Recalls of prescription drugs are rare, and according to an expert interviewed by MarketWatch, are usually “reserved for settings in which there’s an especially untenable risk that can’t be managed through other regulatory actions.”
They often follow action by the FDA, but the agency has yet to take any formal action in connection with Zinbryta.