The U.S. Food and Drug Administration (FDA) has announced it will consider marketing approval of 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 a Biologics License Application (BLA) with 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 assess ZINBRYTA 150 mg (DECIDE and SELECT), during which investigators administered the treatment subcutaneously in patients with relapsing-remitting MS. Prior to this new filing, both companies had already been granted a Marketing Authorization Application for ZINBRYTA by the European Medicines Agency to be reviewed in the European Union.
“We are pleased by the FDA’s acceptance of our BLA for ZINBRYTA, which we believe has the potential to help people living with MS,” stated Gilmore O’Neill, the vice president for Multiple Sclerosis Research and Development at Biogen, in a press release. “We look forward to working with both U.S. and European regulatory authorities to bring this investigational treatment to MS patients as soon as possible.”
“This 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,” added the executive vice president for Research and Development and Chief Scientific Officer at AbbVie, Michael Severino, MD.
The investigational treatment ZINBRYTA is a novel form of a humanized monoclonal antibody that can target and connect to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25). The subunit is present in T-cells in 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 6th 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 on 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). 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.