Monthly Injection Approved for Patients with Relapsed Multiple Sclerosis

Web Exclusives - FDA Approvals, News & Updates, In the News

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 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.

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 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.

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.

US Food and Drug Administration. FDA approves Zinbryta to treat multiple sclerosis. Updated May 27, 2016.

Related Items
First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
Yvette Florio Lane
Web Exclusives published on June 12, 2019 in FDA Approvals, News & Updates, In the News
Welcome to the Fourth Annual Oncology Guide to New FDA Approvals
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates
New Indications Approved by the FDA in 2018 for Oncology Drugs
Dalia Buffery, MA, ABD
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates
FDA Approvals of Novel Brand-Name Prescription Cancer Drugs in 2018
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates
Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates, Melanoma
Copiktra (Duvelisib) Approved for Relapsed or Refractory CLL, SLL, and Follicular Lymphoma
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates, Lymphoma
Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy
Loretta Fala, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates, Leukemia
Erleada (Apalutamide) First Drug Approved by the FDA for Nonmetastatic Castration-Resistant Prostate Cancer
Loretta Fala, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates, Prostate Cancer
Imbruvica (Ibrutinib) plus Rituxan (Rituximab) New Combination Approved for the Treatment of Waldenström’s Macroglobulinemia
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates, Lymphoma
Infugem (Gemcitabine) First Formulation of Premixed, Ready-to-Administer Intravenous Chemotherapy Approved for Several Tumor Types
Lisa A. Raedler, PhD, RPh, Medical Writer
2019 Fourth Annual Oncology Guide to New FDA Approvals published on June 5, 2019 in FDA Approvals, News & Updates
Last modified: February 19, 2019