Once-monthly, self-injected treatment offers new option for people living with active disease.

A new, first-in-class treatment which is believed to use a double-action approach to fight MS by rebalancing the immune system, has today been authorised in the UK for people living with relapsing forms (the most common type) of the disease. ZINBRYTA™ (daclizumab) offers once-monthly, self-injected dosing, and has demonstrated its ability to reduce the frequency of relapses (attack of symptoms) and the risk of disease progression. Daclizumab trials included SELECT and DECIDE, the largest clinical trial ever undertaken in MS.1

How does daclizumab work?

Daclizumab is thought to work by targeting and blocking the growth of activated T cells, which are known to gradually damage myelin, and eventually damage the central nervous system (CNS). Additionally, daclizumab increases the number of natural killer cells in the body, strengthening their natural ability to find and kill existing activated T cells. By rebalancing the immune system, daclizumab is thought to help protect against damage within the CNS.2 Clinical studies have shown that daclizumab positively impacts relapse rates, disability progression, brain lesions (detected through MRI scans), and cognitive function in MS, along with a generally manageable safety profile.1

Professor Gavin Giovannoni, Chair of Neurology at Barts and The London School of Medicine and Dentistry and daclizumab study investigator comments, "The authorisation of daclizumab is another step forward in the fight against MS. The fact that it works in a different way to other therapies not only furthers our understanding of this complex disease, but also importantly gives patients and clinicians an additional treatment option to consider - which is vital because the course of the condition can be so different from patient-to-patient."

MS affects approximately 100,000 people in the UK, and 2-3 times as many women as men have the condition. In MS, the body's immune system causes inflammation, which damages the protective coating (myelin) around the nerves in the CNS, stopping the nerves from working properly. Symptoms of MS vary from patient-to-patient, but can include loss of mobility, speech problems and cognitive problems such as difficulty with thinking and memory.3

60% of people living with MS not taking a treatment4

In a recent survey amongst MS-specialists in the UK, 96% believed that there are people with MS who are eligible, but not currently taking, a treatment who could benefit from reconsidering their decision in light of the additional therapeutic choices now available.5 Active management of the disease is important as MS is not a static condition, but instead progresses over time. This can lead to irreversible development, or increased severity, of a number of symptoms. Even more worrying is that even when symptoms aren't present, underlying damage to the brain can be happening, leading some specialists in the area to urge patients to consider treatment early in the disease course.6

"We are pleased to offer daclizumab as an additional treatment option for relapsing forms of MS in the UK, and we look forward to working with reimbursement bodies over the coming months to support access for eligible patients" comments Terry O'Regan, Vice President and Managing Director of Biogen UK and Ireland. "There has been great innovation in the MS field in recent years but we still have too many patients who are falling short of optimal health outcomes, and we have a responsibility as a company with great heritage in this area to continue our search for pharmacological solutions, whilst also supporting the MS community more broadly".

About ZINBRYTATM (daclizumab)

Daclizumab is a targeted, humanised monoclonal antibody with non-depleting and reversible effects on the immune system. It is thought to work differently from other disease-modifying MS therapies by limiting the inflammation caused by activated T cells (known to damage myelin within the CNS, the underlying biology of relapsing MS). Daclizumab blocks the activation and proliferation of activated T cells, as well as increasing the number of immunomodulatory CD56bright natural killer cells (NK cells), which have been shown to selectively decrease activated T cells. Together, these effects of daclizumab are believed to reduce CNS pathology in MS and thereby reduce the occurrence of relapses and disability progression.2

Daclizumab is authorised in the United States and the European Union and is under regulatory review in Canada, Australia and Switzerland.7

Biogen holds the marketing rights for ZINBRYTATM in Europe.

Clinical studies:

  • Daclizumab halved relapses during the first year compared to placebo (0.21 vs. 0.46),8 and when compared to existing treatment, interferon beta-1a, daclizumab achieved a 45% reduction in relapses (0.22 vs. 0.39) over 2-3 years.9
  • Daclizumab reduced the risk of 12 week-confirmed disability progression by a significant 57% vs. placebo (6% vs. 13%) over 1 year and a non- significant 16% relative reduction vs. interferon beta-1a (12% vs. 16%) over 2-3 years.1 Daclizumab also reduced the risk of 24 week-confirmed disability progression by a significant 76% (3% vs. 11%) when compared with placebo over 1 year,1 and by a significant 27% vs. interferon beta-1a (9% vs. 12%) over 2-3 years.1
  • Daclizumab reduced the mean number of lesions in the brain (Gd lesions) by 75% (0.4 vs. 1.0) when compared to patients treated with interferon beta-1a over 2-3 years.1
  • People treated with daclizumab achieved more than double (+6.30 vs +3.09) the improvements in cognitive function compared to interferon beta-1a-treated patients over 2-3 years.10

As with all MS therapies, daclizumab is associated with some risk of side effects. Daclizumab has been associated with skin reactions (the majority [94%] of which were mild or moderate), infection (with less than 1% discontinuing treatment), and hepatic events including severe hepatic injury - as a result, liver function testing prior to, and monitoring during, treatment should be conducted.1,11 Please see safety information for full details of potential adverse events.1 Daclizumab is available in the form of an autoinjector, which can be administered without the patient having to see the needle.1