The National Institute for Health and Care Excellence (NICE) has recommended ZINBRYTA (daclizumab) from Biogen for the treatment of adult patients living with relapsing-remitting multiple sclerosis (RRMS).
The Final Appraisal Determination (FAD) recommends that daclizumab be considered as a treatment option for patients with active, relapsing-remitting multiple sclerosis who have failed to respond to first-line, disease-modifying therapy, or patients with rapidly evolving severe (RES) relapsing-remitting multiple sclerosis (which is defined as a patient who experiences two or more relapses a year, as well as brain lesions). This recommendation is based on consideration of alemtuzumab suitability.
Professor Gavin Giovannoni, chair of Neurology at Barts and The London School of Medicine and Dentistry comments, “The NICE recommendation of daclizumab is positive news for people living with MS in the UK. MS is a complex and heterogenous condition, and it is important for patients to have options that will help them to continue living full and independent lives. Daclizumab provides an alternative mechanism of action (MOA); it does not broadly deplete the immune system and is reversible within six months, while also increasing natural killer cells, which has proven to be an important biomarker in treatment efficacy with this therapy. Daclizumab will provide an additional option for patients who are experiencing active symptoms of MS, and offers further, much needed, choice for patients when deciding how to sequence therapies throughout the course of the disease.”
According to a press release, 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, which are known to gradually damage myelin within the central nervous system (CNS), the underlying biology of RMS. 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.
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.
“Biogen is delighted that NICE has made the decision to recommend daclizumab as a treatment option for people living with active MS despite previous treatment or rapidly evolving severe MS,” says Terry O’Regan, vice president and managing director of Biogen UK and Ireland. “In this patient group there was a particular need for more treatment options and we are therefore thrilled with the NICE Final Appraisal Decision. Daclizumab has been proven to be more effective versus intramuscular interferon-beta-1a in a clinical trial across a number of endpoints. Daclizumab’s unique mode of action, together with its convenient once-monthly dosing, offers patients an effective treatment choice against MS, whilst re-balancing the immune system. We look forward to making daclizumab available to eligible patients via the NHS in the coming months.”