FDA Evaluates ZINBRYTA For MS Treatment

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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The U.S. Food and Drug Administration (FDA) has announced it willĀ considerĀ marketing approval ofĀ ZINBRYTA (daclizumab high-yield process), a potential treatment for relapsing forms of multiple sclerosis (MS). Biogen and AbbVie, who are jointly developing the therapy, have filed aĀ Biologics License Application (BLA) withĀ the FDA in hopes of winning approval.

The two companies issued the request to the FDA along with data from two pivotal trials conducted to assessĀ ZINBRYTA 150 mg (DECIDE and SELECT), duringĀ which investigatorsĀ administered the treatment subcutaneously in patients withĀ relapsing-remitting MS. Prior to this new filing, bothĀ companies had already been granted a Marketing Authorization Application for ZINBRYTA by the European Medicines Agency to beĀ reviewed in the European Union.

ā€œWe are pleased by the FDAā€™s acceptance of our BLA for ZINBRYTA, which we believe has the potential to help people living with MS,ā€ stated Gilmore Oā€™Neill,Ā theĀ vice president for Multiple Sclerosis Research and Development at Biogen,Ā in aĀ press release. ā€œWe look forward to working with both U.S. and European regulatory authorities to bring this investigational treatment to MS patients as soon as possible.ā€

ā€œThis is an important milestone in the development program for ZINBRYTA and moves us a step closer to potentially bringing a new treatment option to patients with MS,ā€ added theĀ executive vice president for Research and Development and Chief Scientific Officer at AbbVie,Ā Michael Severino, MD.

The investigational treatmentĀ ZINBRYTA is a novel form of a humanized monoclonal antibody that canĀ target and connect to theĀ high-affinity interleukin-2 (IL-2) receptor subunit (CD25). The subunit is present inĀ T-cells inĀ high levels in patients with MS, and the therapy is expected to influence natural killer (NK) cells that impact the immune system regulation.

Last September, the two companies were present at the 6thĀ Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS-ECTRMIS) to showcase the results of their phase 3 clinical trial onĀ ZINBRYTA, demonstrating its effectiveness in relieving the symptoms experienced due to MS.

Patients saw a statistically significant reduction in disease activity when compared to patients treated with the established treatment, AVONEX (interferon beta-1a).Ā 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.