On May 27, 2016, the FDA approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Zinbryta is a long-acting injection that is self- administered by the patient monthly. Zinbryta is manufactured by Biogen, Inc. of Cambridge, MA.
“Zinbryta provides an additional choice to patients who may require a new option for treatment,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function (relapses) are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Most people experience their first symptoms of MS between the ages of 20 and 40.
Zinbryta should generally be used only in patients who have had an inadequate response to two or more MS drugs because Zinbryta has serious safety risks, including liver injury and immune conditions. Because of the risks, Zinbryta has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy.
The boxed warning tells prescribers that the drug can cause severe liver injury, including life-threatening and fatal events. Health care professionals should perform blood tests to monitor the patient’s liver function prior to starting Zinbryta, monthly before each dose, and for up to six months after the last dose.
The boxed warning also highlights other important risks of Zinbryta treatment including immune conditions, such as inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy).
Additional highlighted warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal ideation.
See the FDA Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, August 2016 Report: Diagnosing and Treating Multiple Sclerosis; Liability Considerations (to be published August 2, 2016)