Multiple sclerosis

FDA approves Zinbryta to treat multiple

sclerosis

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For Immediate Release

May 27, 2016

Release
The U.S. Food and Drug Administration today 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 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 FDAs
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.
The effectiveness of Zinbryta was shown in two clinical trials. One trial compared Zinbryta
and Avonex in 1,841 participants who were studied for 144 weeks. Patients on Zinbryta had
fewer clinical relapses than patients taking Avonex. The second trial compared Zinbryta with
placebo and included 412 participants who were treated for 52 weeks. In that study, those
receiving Zinbryta had fewer relapses compared to those receiving placebo.
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 lifethreatening and fatal events. Health care professionals should perform blood tests to monitor
the patients 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.
The most common adverse reactions reported by patients receiving Zinbryta in the clinical
trial that compared it to Avonex include cold symptoms (nasopharyngitis), upper respiratory
tract infection, rash, influenza, dermatitis, throat (oropharyngeal) pain, eczema, and
enlargement of lymph nodes. The most common adverse reactions reported by patients
receiving Zinbryta when compared to placebo are depression, rash, and increased alanine
aminotransferase.
Zinbryta is manufactured by Biogen, Inc. of Cambridge, Massachusetts.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the
public health by assuring the safety, effectiveness, and security of human and veterinary
drugs, vaccines and other biological products for human use, and medical devices. The
agency also is responsible for the safety and security of our nations food supply, cosmetics,
dietary supplements, products that give off electronic radiation, and for regulating tobacco
products.