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FDA Approves Zinbryta™ (Daclizumab) For Relapsing MS

May 27, 2016

UPDATED August 8, 2016
Summary
  • The FDA has approved Zinbryta™ (daclizumab, Biogen and AbbVie) as a disease-modifying therapy for adults with relapsing forms of MS.
  • Zinbryta is an immune-modulating therapy taken by under-the-skin injection every 4 weeks.
  • In a phase 3 trial, Zinbryta was shown after nearly 3 years to reduce annual relapse rates by 45% and to significantly reduce disease activity observed on MRI scans compared to Avonex® (interferon beta-1a, Biogen). Zinbryta was also shown to reduce the relapse rate by 54% compared to the placebo in a smaller, shorter phase 2 trial.
  • Because of its safety profile, the prescribing information indicates that use of Zinbryta should generally be reserved for people who have had an inadequate response to two or more MS therapies.
  • The National MS Society will release additional information as soon it becomes available to us. 
“The approval of Zinbryta provides an important new therapeutic option for people with relapsing MS,” said Kathleen Costello, MS, ANP-BC, MSCN, Vice President, Healthcare Access at the National MS Society. “Early and ongoing treatment is currently the best way we know to reduce future disease activity for people with relapsing forms of MS,” she added.
 
Details
The U.S. Food and Drug Administration has approved Zinbryta™ (daclizumab, Biogen and AbbVie) as a disease-modifying therapy for adults with relapsing forms of MS. Zinbryta, an immune-modulating therapy taken by under-the-skin injection every 4 weeks, is a highly concentrated liquid formulation of daclizumab.
 
About Zinbryta: Daclizumab is a laboratory-created monoclonal antibody that targets a docking site (receptor) for a key immune signaling chemical called interleukin-2 (IL-2). IL-2 is required to activate the immune T cells that are involved in MS attacks. By blocking the receptor, daclizumab inhibits certain inflammatory functions of T cells. Daclizumab also increases important immune cells that help regulate the immune system. These cells are able to enter the brain and spinal cord and modulate MS inflammation.
 
Potential benefits: Zinbryta was tested in a Phase 3 study involving 1,841 people with relapsing-remitting MS, which showed that Zinbryta reduced the rate of relapses by 45% and also reduced disease activity observed on MRI scans over the course of 144 weeks (nearly 3 years) compared to Avonex® (interferon beta-1a, Biogen). In this trial, called the DECIDE trial, participants were randomly assigned to receive either 150 mg Zinbryta injected under the skin every 4 weeks, or Avonex injected once weekly, for up to 144 weeks. Participants also received placebo versions of Avonex or Zinbryta as a control measure. The study was led by Ludwig Kappos, MD (University Hospital, Basel, Switzerland), and the results were published in the New England Journal of Medicine (2015; 373:1418-142).
 
Zinbryta was also tested in a Phase 2 study involving more than 400 people with relapsing-remitting MS. Over one year, one-third of the participants received a lower dose of Zinbryta (150mg), one-third received a higher dose (300 mg), and one-third received inactive placebo. Results suggested that the lower dose of Zinbryta reduced the relapse rate by 54% compared to the placebo. The results of this study were published in The Lancet (Volume 381, No. 9884, p2167–2175, 22 June 2013).
 
Potential risks: Because of its safety profile, the prescribing information indicates that use of Zinbryta should generally be reserved for people who have had an inadequate response to two or more MS therapies. The prescribing information includes a boxed warning about the potential for severe liver injury, including life-threatening and fatal events. 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 thoughts. Zinbryta will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems.
 
The most common side effects were skin rash and elevated liver enzymes. Serious infections also occurred. In people treated with Zinbryta compared to Avonex, there was an increased incidence of serious infections (4% versus 2%), serious skin reactions, elevated liver enzymes and liver injury, gastrointestinal disorders, and depression.
 
FDA screening and monitoring recommendations: The FDA recommends that health care professionals perform blood tests to monitor the individual’s liver function prior to starting Zinbryta, as well as monthly before each dose, and for up to six months after the last dose.
 
For more information about support services provided by Biogen, people can contact the company’s Above MS TM Program. Above MS is available by phone at 1-800-456-2255,
Monday-Friday, 8:30 a.m.-8 p.m. ET.

The National MS Society will release additional information as soon as it becomes available to us.
 
Read the FDA’s press release
Download the Medication Guide (designed for patients)
Download the Prescribing Information (designed for healthcare providers)
Read more about disease-modifying therapies and other treatments for MS and MS symptoms
 
Zinbryta is a trademark of Biogen and AbbVie
Avonex is a registered trademark of Biogen

Frequently Asked Questions About Zinbryta for Relapsing MS

Q. What is Zinbryta?
A. Zinbryta (daclizumab) is a laboratory-created monoclonal antibody that targets a docking site (receptor) for a key immune signaling chemical called interleukin-2 (IL-2). IL-2 is required to activate the immune T cells that are involved in MS attacks. By blocking the receptor, daclizumab inhibits certain inflammatory functions of T cells. Daclizumab also increases important immune cells that help regulate the immune system. These cells are able to enter the brain and spinal cord and modulate MS inflammation.
 
Q. How is Zinbryta taken?
A. Zinbryta is taken by self-injection under the skin every four weeks. Usually these types of subcutaneous injection are done by the individual who is prescribed the medication, or a loved one, after being given training in the procedure.
 
Q. When will Zinbryta be available by prescription?
A. Zinbryta is now available by prescription.
 
Q. How effective is Zinbryta?
A. In the Phase 3 trial, Zinbryta reduced the rate of relapses by 45% and also significantly reduced disease activity observed on MRI scans over the course of 144 weeks (nearly 3 years) compared to Avonex® (interferon beta-1a, Biogen). Zinbryta was also shown to reduce the relapse rate by 54% compared to the placebo in a smaller, shorter phase 2 trial.
 
Q. What are the potential side effects of Zinbryta?
A. The prescribing information includes a boxed warning about the potential for severe liver injury, including life-threatening and fatal events. 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 thoughts. Zinbryta will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems.
 
The most common side effects were skin rash and elevated liver enzymes. Serious infections also occurred. In people treated with Zinbryta compared to Avonex, there was an increased incidence of serious infections (4% versus 2%), serious skin reactions, elevated liver enzymes and liver injury, gastrointestinal disorders, and depression.
 
Q. Will any medical monitoring be needed if I take Zinbryta?
A. Yes. The FDA recommends that health care professionals perform blood tests to monitor the individual’s liver function prior to starting Zinbryta, as well as monthly before each dose, and for up to six months after the last dose. Individuals taking Zinbryta will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems. 
 
Q. How does Zinbryta compare to other available MS therapies?
A. The only therapy that Zinbryta has been compared to in a controlled clinical trial is Avonex. In that trial, Zinbryta was shown to more effectively reduce relapse rates and MRI-detected signs of disease than Avonex. Because the clinical trials that led to the approval of the disease-modifying therapies were conducted differently, using different patient populations and characteristics, it is not possible to compare Zinbryta to other MS therapies.
 
Q. Why should a person with MS consider taking a disease-modifying therapy?
A. Early and ongoing treatment helps to minimize the inflammation, damage to nerve fibers (axons), and loss of brain tissue that take place early in the disease course. This damage can occur even in the absence of symptoms. These findings indicate that the best chance for reducing long-term disability is during the early relapsing phase of the disease. Given the medications that are currently available – all of which primarily target inflammation – early treatment is key, with the goal being to slow the accumulation of lesions, decrease the number of relapses, and prevent disease progression.

Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
 
Q. Should I switch to Zinbryta from my current therapy?
A. The decision about whether to take Zinbryta should be made in collaboration with your MS doctor, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your doctor in terms of Zinbryta include:
  • How am I doing on my current therapy?
  • What is my tolerance for the risk of known side effects?
  • How will my medication choice affect my ability or plans to become pregnant?
  • What are the comparative costs of my current therapy versus Zinbryta? 
Q. Will patient support services be available to people who are prescribed Zinbryta?
A. At this point we do not have specific information on support services that may be provided. If and when this information becomes available, we will provide updates.
  
Q. What will Zinbryta cost?
A. The actual cost to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.
 
Q. Will my health insurance cover Zinbryta?
A. Coverage will depend on individual insurance plans.
 
Q. Is there a generic form of Zinbryta?
A. No. 
 
Q. Are there other disease-modifying therapies available or in development for MS?
A. Yes, there are over a dozen disease-modifying therapies available. Read more about them here. Other potential therapies in later stages of development for relapsing MS include laquinimod and ocrelizumab. Read more about ongoing clinical trials in MS 
 
Q. Why aren’t there more treatments for progressive MS?
A. Nearly every therapy approved for relapsing MS has been tested, or is now in testing, in people with progressive forms of the disease, including primary-progressive MS and secondary-progressive MS. Up to now, clinical trials involving people with relapsing MS often rely on counting relapses or doing MRI scans to detect immune activity. The fact that there is no easy way to detect progression quickly is one reason why development of therapies for progressive MS is behind. The National MS Society is investing in better ways to detect benefits of therapies for progressive forms of MS. In addition, the international Progressive MS Alliance is a global effort to speed research and treatments on progressive MS. In the fall of 2015, the first positive results were announced from a large-scale clinical trial in primary progressive MS (from a trial of ocrelizumab), renewing hope that treatments are on the horizon for people with progressive MS. There are other large clinical trials going on in progressive MS, including tests of Ibudilast, Siponimod and Masitinib. Download a table of trials on focusing on progressive MS (.pdf)
 
Q. I’ve been hearing news about other new treatments in development for MS. What are some details?
A. Oral and infrequent-dose disease-modifying therapies are just two of many exciting research avenues that address ways to stop MS progression, restore function and end MS forever. Just a few new approaches being explored include adult stem cell transplantation, clinical trials for progressive MS, trials of agents aimed at protecting or repairing the nervous system, and studies of vitamin D and antioxidants.
 
Q. Is Zinbryta being tested in progressive MS?
A. Not at this time. 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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