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European drug regulators confirm that the potential brain inflammation risks with Zinbryta outweigh any possible benefits that may be provided by the multiple sclerosis drug, which was recently removed from the global market amid reports of encephalitis, meningoencephalitis and other problems.
In a press release issued on May 18, the European Medicines Agency (EMA) indicates that its Pharmacovigilance Risk Assessment Committee (PRAC) found that Zinbryta (dacilzumab beta) carries a risk of deadly immune system problems, which could lead the body to attack the liver, brain and other organs.
Zinbryta is a multiple sclerosis injection drug that was introduced by Biogen and AbbVie in 2016. In the U.S. it was only available through a Risk Evaluation and Mitigation Strategy (REMS) program, and was recommended as a treatment for individuals who failed to respond to other first-line MS drugs, resulting in limited prescriptions over the few years it was on the market.
In March 2018, the manufacturers announced a Zinbryta recall to phase the drug off the market, following an alarming number of reports involving severe and potentially lethal brain inflammation cases.
The action 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.
According to the FDA, the Zinbryta market withdrawal was completed by April 30.
PRAC continued its assessment, confirming that the Zinbryta brain inflammation risks outweighed its benefits, according to the press release.
“Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected,” the press release notes. “The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.”
Only about 10,000 individuals worldwide have used Zinbryta, according to PRAC, highlighting the serious brain inflammation risks with at least 12 reports known to be linked to use of the drug.
At least three Zinbryta deaths have been reported, all of which occurred in the United States, which led the FDA to launch an investigation into the reports. The agency was reassessing the drug’s safety profile when European regulators and the manufacturers decided the drug should be pulled from the market.
Patients with questions or concerns can contact the manufacturers’ service center by calling 1-800-456-2255 or by visiting the drug website at www.zinbryta.com. The FDA also urges health care professionals and consumers to report any adverse reactions to the FDA’s MedWatch adverse event reporting program.