Daclizumab high-yield process (HYP) is a humanized monoclonal antibody that binds to CD25 (alpha subunit of the interleukin-2 receptor) and modulates interleukin-2 signaling. Abnormalities in interleukin-2 signaling have been implicated in the pathogenesis of multiple sclerosis and other autoimmune disorders.

Currently Zinbryta is awaiting FDA approval in the United States.  Administered subcutaneously in patients with relapsing-remitting MS, both companies had already been granted a Marketing Authorization Application for ZINBRYTA by the European Medicines Agency to be reviewed in the European Union.

In previous news releases Biogen stated that patients saw a statistically significant reduction in disease activity when compared to patients treated with the established treatment, AVONEX (interferon beta-1a). This positive data was generated through the two- to three-year phase 3 study of more than 1,800 relapse-remitting multiple sclerosis patients from 28 countries. Patients were given either 150 mg subcutaneous ZINBRYTA every four weeks or 30 mcg intramuscular AVONEX once weekly.

Phase III Clinical Trial Data:

The phase III DECIDE trial shows good results and was published on October 8th in The New England Journal Of Medicine.

Compared against interferon β-1a (Avonex) shoed both a lower relapse rate and less numbers of lesions on MRI scans with Zinbryta (daclizumab).  Disability progression was not significantly reduced in the first three months of the DECIDE trial but at a 6 month term of time disability progression was reduced.

Other data released at ECTRIMS 2015 (European Committee for Treatment and Research in Multiple Sclerosis) displayed that patients who received Zinbryta showed no evidence of disease activity at 2 years of time!

The data shows nearly twice the amount of people who were administered Zinbryta had no disease activity in comparison to (interferon beta-1a) Avonex.  This means no new lesions, no relapses and no disability progression! Zinbryta was shown to also improve cognition and cognitive processing speeds.

Some 2.236 relapsing remitting multiple sclerosis patients from six clinical studies with 211 of the patients treated for more than 5 years and 888 for more than three years showed when compared to interferon β-1a (Avonex) that skin related adverse events occurred more with Zinbryta at a rate of 37% .vs. 19% a 18% increase.

Zinbryta is administered by subcutaneous injection (under the skin) once per month and is awaiting marketing approval in the United States and Europe.

 


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