Earlier this week, foreign health officials raised concerns about side effects of Zinbryta, following cases of brain inflammation and at least three deaths among U.S. residents, and the manufacturers have announced that the new-generation multiple sclerosis drug will be removed from the market worldwide.
Biogen Inc. and AbbVie have issued a press release announcing a Zinbryta recall, indicating they are voluntarily withdrawing the drug from the market following a number of reports of severe and potentially deadly brain problems, including encephalitis and meningoecephalitis.
The move came as the European Medicines Agency (EMA) moved to ban the drug amid reports of Zinbryta deaths, and at least a dozen reports of brain inflammation.
The pharmaceutical companies indicate that the small number of patients using Zinbryta makes it impossible to safely and adequately characterize the number of complex and evolving adverse events linked to the drug.
At least three deaths on Zinbryta have been reported, all of which occurred in the United States, where the FDA recently launched an investigation into the reports and was reassessing the drug’s safety profile.
Zinbryta (daclizumab) is an Biogen and AbbVie injection drug that was introduced in both the United States and the E.U. in 2016. The FDA has approved Zinbryta for the treatment of adult patients with relapsing forms of multiple sclerosis. Due to a risk of liver injury linked to Zinbryta side effects, the drug is currently subject to a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S., and regulators only recommend it as a treatment for individuals who have failed to respond to other first-line MS drugs.
Only about 8,000 individuals worldwide have used Zinbryta, highlighting the serious brain inflammation risks with at least 12 reports known to be linked to use of the drug.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” Dr. Alfred Sandrock, executive vice president and chief medical officer at Biogen, said in the press release. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”
Earlier this week, the EMA recommended that no new patients start Zinbryta treatment, and that doctors immediately contact patients using Zinbryta and instruct them to stop treatment and consider alternatives. The agency also advised doctors to follow up with patients who used Zinbryta for at least six months after to check for brain inflammation or liver damage; the latter of which has been a known risk for some time.
Biogen’s press release indicates that the company will work with regulatory agencies and doctors worldwide on the removal of Zinbryta from the market and the support of affected multiple sclerosis patients. The drug was available in the United States, the European Union, Canada, Switzerland and Australia.