Zinbryta (daclizumab), a humanized monoclonal antibody produced by Biogen and AbbVie, is an approved treatment for relapsing multiple sclerosis (RMS) in the U.S. and in Europe.

How Zinbryta works

Zinbryta is a formulation of a monoclonal antibody against the CD25 subunit of interleukin 2 (IL-2) receptors. These receptors are highly expressed on reactive T-cells in MS patients. By selectively targeting the T-cells with CD25, Zinbryta prevents the expansion of CD25-positive, autoreactive T-cells. It further promotes the activity of CD 65-positive natural killer cells, which clean up the already activated CD25-positive T-cells. Therefore, Zinbryta both stops and prevents inflammation caused by CD25-positive T-cells.

In the high-yield formulation, Zinbryta is intended to be administered subcutaneously (beneath the skin) once every four weeks. At this dose, Zinbryta binds to all CD25 receptors within 10 hours and remains bound for 64 days.

History of Zinbryta

Daclizumab was originally pursued for the treatment of acute organ rejection in patients with kidney transplants by Roche under the trade name Zenapax. The medication was available in the U.S. and European Union, but it was withdrawn for commercial reasons. Daclizumab is now called Zinbryta for use in RMS patients. Two clinical trials, DECIDE (NCT01064401) and SELECT (NCT00390221), formed the basis of the biological licence application (BLA) submission to the U.S. Food and Drug Administration (FDA) by Biogen and AbbVie.

The SELECT study compared the effect of different doses of daclizumab (300 mg and 150 mg) to placebo over a one-year period in participants with RMS and showed that the lower dose of daclizumab (150 mg) reduced the relapse rate by 54% compared to placebo.

DECIDE, a Phase 3 study involving 1,841 participants with RMS, showed that Zinbryta reduced the rate of relapses by 45% and also decreased the activity of the disease, as observed in MRI scans, over 144 weeks compared to Avonex, another drug approved for the treatment of RMS.

Next steps for Zinbryta

The FDA accepted Biogen and Abbvie’s BLA for Zinbryta for RMS, and Zimbryta was officially approved by the FDA on May 27, 2016.

The European Medicines Agency (EMA) also validated the Marketing Authorization Application for Zinbryta for the treatment of RMS, and a review process by EMA’s Committee for Medicinal Products for Human Use (CHMP) began in March 2015. About a year later, in April 2016, CHMP adopted a positive opinion, recommending marketing authorization in Europe for  Zinbryta to treat RMS.

The EMA eventually approved Zinbryta for the treatment of adult patients with RMS in July 2016.

The decision was followed by the National Health Service (NHS) in England and Wales in March 2017 and by the Scottish Medicines Consortium (SMC) on April 10, 2017.

In England and Wales, Zinbryta is indicated for the treatment of RMS in patients who have relapses while taking one of the other available disease modifying drugs, and for the treatment of rapidly evolving RMS when there were two or more relapses in the previous year as measured with magnetic resonance imaging (MRI).

In Scotland, Zinbryta can be prescribed for rapidly evolving severe RMS, or RMS with inadequate response to disease modifying therapy.

The benefits of Zinbryta in patients with secondary progressive MS (SPMS) have also been investigated, by PDL BioPharma, in 2008. Eight percent of the patients enrolled in a Phase 2 clinical trial (NCT00109161) had SPMS (the other 92% had RMS).

Other Zinbryta info

Zinbryta has a black box warning about the potential for severe liver injury, including life-threatening and fatal events. Therefore it is highly recommended that liver function is monitored before starting and during treatment with Zinbryta. Common side effects include skin rash and elevated liver enzymes.

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