Multiple Sclerosis Drug Pulled Due to Brain Inflammation Risks
Daclizumab (Zinbryta) may cause brain inflammation among patients with relapsing multiple sclerosis.
Biogen and AbbVie recently announced a voluntary worldwide withdrawal of daclizumab (Zinbryta) for relapsing multiple sclerosis (MS), according to a press release.
Daclizumab is available in the European Union, United States, Switzerland, Canada, and Australia for the treatment of relapsing MS. Due to the known risks of the drug, daclizumab is typically administered to patients who have failed 2 previous MS treatments, according to the release.
The withdrawal of daclizumab from the market is due to an inability to characterize the complex and evolving risk profile of the drug due to the few patients treated, according to the release. Therefore, the companies have voluntarily withdrawn the drug.
Biogen also noted that the European Medicines Agency initiated an Article 20 referral procedure after several reports of inflammatory encephalitis and meningoencephalitis among patients treated with daclizumab.
The companies plan to collaborate with regulatory authorities and health care providers worldwide to facilitate the withdrawal. Patients with MS who are currently taking daclizumab should contact their providers to discuss other treatment options, according to the release.
“Biogen believes the voluntary worldwide withdrawal of Zinbryta, a treatment for relapsing multiple sclerosis, is in the best interest of patients,” said Alfred Sandrock, MD, PhD, executive vice president and chief medical officer at Biogen. “Biogen and AbbVie continue to prioritize patient safety and the care of multiple sclerosis patients worldwide.”