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Pipeline Drug: ZINBRYTA Evaluated by FDA for MS Treatment

August 19, 2015

ZINBRYTA is a potential treatment for relapsing forms of multiple sclerosis that is being considered for marketing approval by the U.S. Food and Drug Administration (FDA).

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

Two companies Biogen and AbbVie are jointly developing this therapy and have filed a Biologics License Application (BLA) in hopes of winning approval after issuing the request to the FDA.

As part of the BLA, they submitted data from two pivotal trials that were conducted to assess the efficacy of ZINBRYTA 150 mg, where investigators had administered the treatment subcutaneously in patients that had relapsing-remitting MS. Before they had even filed these requests, the companies had already secured a Marketing Authorization Application for ZINBRYTA by the European Medicines Agency for review in the European Union.

The vice president for Multiple Sclerosis Research and Development at Biogen, Gilmore O’Neill, says that he, as well as everyone behind the potential treatment, believes that ZINBRYTA could greatly benefit people living with relapsing MS. He also says that the plan is to bring this treatment to MS patients as soon as possible.

When showcased last September, the results of their phase 3 clinical trial on ZINBRYTA demonstrated its effectiveness in relieving MS symptoms. Patients in the trial were given either 150 mg subcutaneous ZINBRYTA every four weeks or 30 mcg intramuscular AVONEX once every week. Patients using ZINBRYTA saw a statistically significant reduction in disease activity when compared to patients that were treated with the already established treatment of AVONEX. This data was generated through the two to three-year phase 3 study with more than 1,800 relapse-remitting MS patients from 28 countries.