Daclizumab (Zinbryta) approved for the treatment of multiple sclerosis (MS)

Last Updated on

May 28, 2016 – Multiple sclerosis (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 American Food & Drug Administration (FDA) has just added an additional treatment option to the armamentarium of drugs to fight MS by approving Daclizumab (Zinbryta) for the treatment of adults with relapsing forms of MS. Daclizumab (Zinbryta) is a long-acting injection that is self-administered by the

Daclizumab: A humanised therapeutic antibody against the IL-2 receptor

Daclizumab: A humanised therapeutic antibody against the IL-2 receptor

patient monthly. Daclizumab (Zinbryta) is a therapeutic humanized monoclonal antibody and works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells. Previously, Daclizumab was already FDA-approved under the trade name Zenapax to prevent rejection in organ transplantation, especially in kidney transplants.

According to FDA, the effectiveness of Zinbryta was shown in two clinical trials. One trial compared Daclizumab (Zinbryta) and Avonex in 1,841 participants who were studied for 144 weeks. Patients on Daclizumab (Zinbryta) had fewer clinical relapses than patients taking Avonex. The second trial compared Daclizumab (Zinbryta) with placebo and included 412 participants who were treated for 52 weeks. In that study, patients receiving Daclizumab (Zinbryta) had fewer relapses compared to those receiving placebo.

Daclizumab (Zinbryta) comes with serious safety risks, however, and should therefore generally be used only in patients who have had an inadequate response to two or more MS drugs previously. The most serious and sometimes fatal safety risks of Daclizumab (Zinbryta) include liver injury and immune conditions. Because of these risks, Daclizumab (Zinbryta) has a boxed warning and is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS). 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 Daclizumab (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 Daclizumab (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 Daclizumab (Zinbryta) when compared to placebo are depression, rash, and increased alanine aminotransferase, a fluid biomarker for disturbed liver function.

Tags: , , , , , , , ,
About the Author
thassodotcom Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

Leave a Reply

Optional: Social Subscribe/Login




avatar
  Subscribe  
Notify of
marip73
Member
marip73

The European Medicines Agency has suspended the licence of Daclizumab (Zinbryta) a multiple sclerosis drug after 12 reports of serious inflammatory brain disorders, three of them fatal.

Daclizumab (Zinbryta) had already been withdrawn voluntarily worldwide by its manufacturers, Biogen and Abbvie because of the complexity of the adverse events being associated with the drug and the drugs benefits no longer outweighed its risks.

See here the final announcement by the EMA:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/05/news_detail_002955.jsp&mid=WC0b01ac058004d5c1

trackback

[…] a été approuvé pour le traitement de la sclérose en plaques (SEP) rémittente cyclique en mai 2016 aux États-Unis, en juillet 2016 dans l’Union européenne (UE) et en janvier 2017 en Suisse. […]

trackback

[…] März 2018 – Daclizumab (Zinbryta) wurde im Mai 2016 in den USA, im Juli 2016 in der Europäischen Union (EU) und im Januar 2017 auch in der Schweiz zur […]

thasso: conditions

thasso: tweets

thasso post: magazine

View my Flipboard Magazine.

thasso: categories

thasso: archives

thasso: simple chat

You must be a registered user to participate in this chat.

  • Development and analytical validation of a next-generation sequencing based microsatellite instabili October 18, 2019
    The referenced article describes an assay that has a clinically relevant five-day turnaround time and can be conducted on as little as 20 ng genomic DNA with a batch size of up to forty samples in a single run.
  • Lifestyle is a threat to gut bacteria: Ötzi proves it October 18, 2019
    The intestinal microbiome is a delicate ecosystem made up of billions and billions of microorganisms, bacteria in particular, that support our immune system, protect us from viruses and pathogens, and help us absorb nutrients and produce energy. The industrialization process in Western countries had a huge impact on its content. This was confirmed by a […]
  • Singapore completes whole genome sequencing analysis of multi-ethnic Asian populations October 18, 2019
    A new genetic databank has been established containing the completed whole-genome sequencing (WGS) data of close to 5,000 Singaporeans. Worldwide, WGS is increasingly used in research and healthcare to identify genetic variations using cutting-edge technologies that allow large numbers of individuals to be sequenced rapidly—This new study is the world's largest WGS analysis of Asian […]
  • Researchers quantify limitations of health reports from direct-to-consumer genetic tests October 17, 2019
    Health reports from direct-to-consumer (DTC) genetic tests that use a limited variant screening approach often yield clinical false-negative results, which pose the risk of informing health care decisions based on incomplete information, according to findings presented at the American Society of Human Genetics (ASHG) 2019 Annual Meeting in Houston, Texas.
  • Researchers develop mouse model of human gene involved in Alzheimer's disease October 17, 2019
    In research that helps scientists better understand and explore treatments for diseases like Alzheimer's, scientists have developed a line of mice in which the mouse version of the Alzheimer's-associated MAPT gene has been fully replaced by the human version of the gene. In this new animal model, known as a full gene-replacement model, the MAPT […]
Top