Biogen’s Daclizumab receives positive opinion to treat multiple sclerosis

4 May 2016 (Last Updated May 4th, 2016 18:30)

US biotechnology company Biogen has announced new data that reveals daclizumab’s positive cognitive outcomes, targeted and reversible mechanism of action (MOA), and safety profile in patients suffering from relapsing-remitting multiple sclerosis (RRMS).

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US biotechnology company Biogen has announced new data that reveals daclizumab's positive cognitive outcomes, targeted and reversible mechanism of action (MOA), and safety profile in patients suffering from relapsing-remitting multiple sclerosis (RRMS).

Information presented from the Phase III DECIDE study demonstrates the positive impact that daclizumab might have on the cognitive capability of patients affected with RRMS.

Cognitive impairment is a common symptom in MS patients and can involve memory decline, impaired executive function, reduced information-processing speed and flawed visual / spatial-processing.

Daclizumab selectively modulates interleukin-2 receptor signalling that leads specific antagonism of pro-inflammatory effector T-cell activity and increased numbers of immune-regulatory CD56 natural killer (NK) cells.

According to the data demonstrated from the SELECT and SELECTION studies, the total reduction and differential lymphocyte counts during treatment were modest and reversible upon treatment discontinuation.

"Additional data revealed from the DECIDE study evaluated cutaneous adverse events (AEs) related to daclizumab."

The CD4+/CD8+ ratio remained consistent in SELECT and SELECTION studies.

The absence of significant depletion of total lymphocytes, CD4+ and CD8+ T cells, as well as CD56 NK cells during treatment and the reversibility of the changes in cell counts, all generate more evidence of the targeted immunomodulatory MOA of daclizumab in RRMS.

Additional data revealed from the DECIDE study evaluated cutaneous adverse events (AEs) related to daclizumab.

The majority (94%) of AEs observed were mild or moderate, while the rate of serious AEs remained low at 2%, and were resolved following topical and / or antihistamines, systemic steroids, other therapies or treatment discontinuation.


Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101.