In a rare move, the companies that make the multiple sclerosis drug daclizumab (brand name Zinbryta) have voluntarily pulled the medication from the market and stopped all clinical studies after reports of eight cases of serious brain inflammation among patients in Europe.
Manufacturers Biogen and AbbVie acted on the same day the European Medicines Agency called for an “urgent review” of the multiple sclerosis medicine.
Seven patients in Germany and one in Spain presented with encephalitis and or meningoencephalitis, which are both inflammation of the brain.
“Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated,” the companies said in a statement.
“Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.”
The drug is available in the European Union, the United States, Switzerland, Canada and Australia. According to the European Medicines Agency, over 8,000 patients around the world have received Zinbryta. The majority of the European patients are in Germany.
Daclizumab is an immune-modulating therapy that was approved by the US Food and Drug Administration in May 2016 for treatment of the type of MS called relapsing-remitting multiple sclerosis. But the FDA warned at the time that the drug could cause “serious or life-threatening liver damage” and “serious immune system disorders (conditions that occur when the immune system attacks healthy cells in the body).”
Patients who were taking medications that affect the liver, those with existing liver disease or anyone who had skin problems such as eczema or psoriasis were not candidates for the monthly injection. In addition, patients who wanted to use the medication must have tried at least two other disease-modifying treatments and could not be on any other multiple sclerosis treatments.
Due to these concerns, the drug was available only via a restricted distribution program that included regular monitoring. A patient’s doctor and pharmacist had to be registered with the program to use the drug.
Multiple sclerosis is a neurological disease that affects more than 2.3 million people worldwide, according to the National Multiple Sclerosis Society. The disease scars nerve tissue and causes a range of symptoms, including vision problems and paralysis.
The European Medicines Agency said it will contact doctors directly in the next few days. Until then, the agency advises that doctors do not start any new patients on the drug and that they should contact existing patients immediately and look for signs of brain inflammation, including fever, seizures, changes in behavior, confusion and disorientation. Treatment for any form of encephalitis is “immediate, aggressive” medical intervention including antibiotics that can cross the blood-brain barrier, according to the National Institutes of Health.
The European Medicines Agency added that patients on daclizumab are advised not to stop their medication without consulting their doctor. Anyone enrolled in a clinical trial of the drug should reach out to their doctor in the study.