Zinbryta (daclizumab)

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Zinbryta (daclizumab)

How to buy Zinbryta: You can order Zinbryta (daclizumab) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Biogen Idec Ltd
Disease Multiple Sclerosis
Indication Relapsing MS
Mode of Action Interleukin-2 blocking antibody (immunotherapy)
Approval Status EMA approved (EU); FDA approved (USA); TGA approved (AUS)
CAS Number 152923-56-3
HS Code 30021091
Strength 150mg

Who is daclizumab for?

Daclizumab is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS) [1][2].
Daclizumab should generally be used only for patients who have had an inadequate response to two or more MS drugs because daclizumab has serious safety risks, including liver injury and immune conditions [3].

Recommended dose

Complete information about daclizumab dosage and administration can be found here [1][2][6].
The recommended therapy consists of
  • a subcutaneous injection of 150 mg/mL solution in a single-dose pre-filled syringe once a month [1][2][6].
Daclizumab can cause unpredictable and potentially fatal immune-mediated liver injury. Several cases of serious liver injury including immune-mediated hepatitis and fulminant liver injury have been reported [7]. Patients should be closely monitored. 

Consult your treating doctor for personalised dosing.

What is daclizumab and how does it work?

Daclizumab is a monoclonal antibody (interleukin-2 receptor blocking antibody) indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (MS) [1][2].
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 [3].
In multiple sclerosis, the body’s immune system incorrectly attacks and damages the protective sheath around the nerve cells in the central nervous system (the brain and spinal cord). Daclizumab is a monoclonal antibody that attaches to T cells. These cells form part of the body’s immune system and they are activated by interleukin-2, a signaling protein in the body. By attaching to the T cells, daclizumab blocks interleukin-2, preventing T cells from attacking and damaging nerve cells. Daclizumab may also have other effects that reduce the immune system’s damaging effects on nerve cells [4].

What is daclizumab's approval status?

Daclizumab was approved by:
  • FDA (USA) on May 27, 2016 [3]
  • EMA (EU) on July 1, 2016 [4]
  • TGA (AUS) on September 22, 2016 [5]
for the treatment of patients with relapsing forms of multiple sclerosis (MS).
The efficacy of daclizumab was investigated in several clinical trials. One trial compared daclizumab and interferon beta-1a in 1,841 participants who were studied for 144 weeks. Patients receiving daclizumab 150 mg every 4 weeks had on average 0.22 relapses over a year compared with 0.39 in those receiving interferon beta-1a [3][4]. Another trial compared daclizumab with placebo and included 412 participants who were treated for 52 weeks. Patients receiving daclizumab had fewer relapses compared to those receiving placebo [3]. In a third study involving 600 patients, daclizumab was found to be more effective than placebo at reducing relapses of the condition. Patients receiving daclizumab 150 mg every 4 weeks had on average 0.21 relapses over a year compared with 0.46 in those receiving placebo [4].
The most common serious side effects of daclizumab are liver damage, and severe skin reactions [1][4]. For the full list of restrictions and of all side effects reported with daclizumab, see the package leaflet [1][2].
References
[1] Summary of Product Characteristics [FDA]: Zinbryta (daclizumab), Biogen, May 2016.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf
[2] Summary of Product Characteristics [EMA]: Zinbryta (daclizumab), Biogen Idec Ltd, Feb. 2017.
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003862/WC500210598.pdf
[3] FDA News Release: FDA approves Zinbryta to treat multiple sclerosis, 27/05/2016.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm504000.htm
[4] EMA. Human Medicines: Zinbryta (daclizumab), 19/07/2016 (last update: 06/02/2017), cited on 30/08/2016.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003862/human_med_001987.jsp&mid=WC0b01ac058001d124
[5] MSRA. Zinbryta has been recommended for inclusion in the PBS, 20/12/2016.
http://www.msra.org.au/zinbryta-receives-tga-approval-use-relapsing-ms
[6] Summary of Product Characteristics [TGA]: Zinbryta (daclizumab), Biogen Australia Pty Ltd, Sep. 2016.
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2016-PI-02547-1&d=2017011216114622483
[7] EMA News Release: EMA concludes review of Zinbryta and confirms further restrictions to reduce risk of liver damage, 10/11/2017
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/11/news_detail_002845.jsp&mid=WC0b01ac058004d5c1

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

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