US biotechnology company Biogen and pharmaceutical company Abbvie have received marketing authorisation from the European Medicines Agency (EMA) for Zinbryta (daclizumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adult patients.
Daclizumab is a targeted, humanised monoclonal antibody with non-depleting and reversible effects on the patient’s immune system.
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It is a once-monthly, self-administered, subcutaneous treatment for adult patients affected with RMS, and offers an additional option for the patients in the UK.
Blizard Institute, Barts and London School of Medicine and Dentistry Neurology chairman Gavin Giovannoni said: "Daclizumab has an immunomodulatory mechanism of action (MOA) that regulates inflammation without broadly depleting the immune system and immune cell effects are reversible within six months.
"This offers an alternative approach to treating multiple sclerosis (MS) and is an important consideration when deciding how to sequence therapies throughout the course of a patient’s disease."
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Daclizumab is believed to work differently from other disease-modifying MS therapies, as it helps restrict the inflammation caused by activated T-cells that can gradually damage myelin within a person’s central nervous system (CNS).
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By GlobalDataThe use of Daclizumab helps block the activation and proliferation of activated T-cells, along with increasing the number of immunomodulatory CD56 bright natural killer cells (NK cells), which in turn can selectively decrease activated T-cells.
These effects of daclizumab help reduce CNS pathology in MS, thereby reducing the occurrences of relapses and disability progression.
Biogen UK and Ireland VP and managing director Terry O’Regan said: "MS is a multi-faceted disease, and each patient has their own individual needs.
"As RMS progresses, it is important to have different treatment options that target different points in the disease pathway, as this is particularly important for patients remaining active whilst on their current therapy.
"Daclizumab offers a new choice for targeting MS, in the form of a first-in-class IL-2 modulator."
Daclizumab has been granted marketing authorisation in the UK based on the results from two clinical trials Select and Decide.
However, the treatment has several adverse effects including infection, skin reactions, and hepatic events such as severe hepatic injury.
Image: Multiple sclerosis as seen on MRI. Photo: courtesy of James Heilman, MD.
