Biogen’s ZINBRYTA (daclizumab) and AbbVie who jointly developed the Zinbryta drug. 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.
The relapsing remitting multiple sclerosis (RRMS) therapy also was recently given a positive opinion by The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending granting of a marketing authorization for ZINBRYTA™. ZINBRYTA is a once-monthly, self-administered, subcutaneous investigational treatment for RMS. ZINBRYTA is also currently under regulatory review in the United States, Switzerland, Canada and Australia.
“For people with relapsing forms of MS (RMS) and active disease, ZINBRYTA has the potential to offer robust efficacy, a manageable safety profile through patient monitoring, and once-monthly subcutaneous dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and chief medical officer at Biogen. “ZINBRYTA may offer another option for people with multiple sclerosis (MS) with its targeted mechanism of action (MOA) which did not cause broad and prolonged immune cell depletion.”
Biogen is one of the world’s leading biotechnology companies, with a focus on developing therapies for neurodegenerative, hematologic and autoimmune disorders. Founded in 1978, our work in biologics and small-molecule drug discovery has led to the world’s most extensive portfolio of multiple sclerosis therapies and innovative new treatments for hemophilia patients. Our experience, capabilities and passion for innovation have enabled us to build a pipeline and develop advanced research programs that include exploration of potential candidates for serious and difficult-to-treat neurodegenerative diseases and fibrotic and nonmalignant blood disorders.
We are committed to research that uncovers the underlying biology of complex diseases. Our focus is on illnesses with few, if any, treatment options. Biogen’s success will always be measured by the answer to a simple question: Have we truly made a difference in the lives of patients?