Zinbryta (daclizumab), a humanized monoclonal antibody produced by Biogen and AbbVie, is an approved treatment for relapsing-remitting MS (RRMS) in the United States and is expected to soon be approved for use 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 avoids general T-cell depletion. 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. Thus, Zinbryta both stops and prevents inflammation caused by CD25-positive T-cells. In the high-yield formulation, Zinbryta is intended to be administered subcutaneously once every four weeks. At this dosing scheme, Zinbryta binds all CD25 receptors within 10 hours and remains bound for 64 days.
History of Zinbryta
Daclizumab was originally pursued for prophylaxis of acute organ rejection in patients with renal transplants by Roche under the trade name Zenapax. The medication was available in the United States and European Union, but it was withdrawn for commercial reasons. Daclizumab is now under investigation for use in RRMS patients by Biogen and AbbVie under the name Zinbryta. Two trials, DECIDE and SELECT, formed the basis of BLA submission by Biogen and AbbVie.
In SELECT, (NCT00390221), the study compared different daclizumab doses (300 mg and 150 mg) with placebo over one year, in participants with RRMS and showed that the lower dose of daclizumab (150 mg) reduced the relapse rate by 54% compared to the placebo.
DECIDE, a phase 3 study involving 1841 people with RRMS (NCT01064401), 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.
Next Steps for Zinbryta
The FDA accepted a Biologics License Application (BLA) for Zinbryta with indications for RRMS, filed by Biogen and AbbVie, on April 29, 2015. Zimbryta was officially approved by the FDA on May 27, 2016.
The European Medicines Agency (EMA) also validated the Marketing Authorisation Application for Zinbryta to treat RRMS, 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 RRMS.
The benefits of Zinbryta in patients with secondary progressive MS (SPMS) have also been investigated, by PDL BioPharma, in 2008: 8% of the patients enrolled in the clinical trial “Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis” had SPMS (the other 92% had RRMS).
Other Zinbryta Info
It is a once-a-month disease-modifying therapy that comes as an under-the-skin injection. It is generally used in people who have already tried 2 or more MS medicines that have not worked well enough.
Zinbryta has a black box warning concerning the potential for severe liver injury, including life-threatening and fatal events, so it is highly recommended that the liver function is monitored before starting and as continuing the treatment. Common side effects are skin rash and elevated liver enzymes.
There are currently no generics available for Zinbryta.
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