Biogen and AbbVie have voluntarily withdrawn global marketing authorizations for their relapsing multiple sclerosis therapy Zinbryta (daclizumab) because of serious side effects that include brain inflammation.
The Europe Medicine Agency, which oversees medications across the European Union, also released a statement recommending a “immediate suspension” of Zinbryta’s use by patients and a recall.
Twelve cases of brain inflammation worldwide may be linked to the medication’s use based on a preliminary review of data, the EMA states. These include cases of encephalitis and meningoencephalitis, or inflammation of the three membranes enveloping the brain and spinal cord. Three people have died.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” Alfred Sandrock, Biogen’s executive vice president and chief medical officer, said in a press release.
“Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide,” Sandrock added.
Given the limited number of patients still receiving the treatment, the companies also said that it’s no longer possible to continue developing a risk-benefit profile for Zinbryta.
Biogen said it will work with regulatory authorities to withdraw Zinbryta and with healthcare providers to support patients who have been affected.
The company said it advises patients who are still taking Zinbryta to contact their healthcare provider with questions or concerns.
Zinbryta is used to treat adults with relapsing forms of MS. Due to its risks, the medication is normally given to patients who have tried two or more MS treatments without success.
The therapy is an antibody engineered to reduce inflammation. It targets MS patients’ T-cells, which are key immune cells in inflammation.
Zinbryta carries a warning on its label about the potential of patients developing a liver injury that could be life-threatening. It advises doctors who prescribe the treatment to keep a close watch on patients’ liver function.
In 2017, the European Medicines Agency restricted the use of Zinbryta to patients who had failed to respond to other MS treatments and those with a rapidly evolving disease who were unable to take other disease-modifying medications. The decision followed reports of patients experiencing severe liver damage and one dying of liver disease.