Zinbryta (daclizumab) is an antibody therapy originally approved for relapsing forms of multiple sclerosis (MS) but it has been withdrawn from the market due to safety concerns.
Developed by Biogen and AbbVie, the therapy was approved in the U.S. in 2016, and also garnered approvals in the European Union, Canada, England, Wales, Scotland, Switzerland, and Australia.
However, the companies withdrew global marketing authorizations for Zinbryta in 2018, due to a risk of serious side effects associated with the therapy, including potentially life-threatening inflammation in the brain, liver, and other organs.
How Zinbryta works
Zinbryta was designed to block CD25, a subunit of the interleukin-2 (IL-2) receptor present on the surface of immune T-cells. By blocking this receptor, the therapy was thought to interfere with molecular signaling pathways that promote the pro-inflammatory activity of T-cells. Preventing this inflammatory activity could lessen the inflammation in the nervous system that drives MS.
Zinbryta in clinical studies
Regulatory approvals of Zinbryta for relapsing MS were supported by data from two clinical trials: the SELECT Phase 2 study (NCT00390221) and the DECIDE Phase 3 trial (NCT01064401).
SELECT enrolled 412 people with relapsing-remitting MS (RRMS) and randomly assigned them to receive Zinbryta or a placebo, given via monthly under-the-skin injections for about one year. Results showed that the treatment significantly reduced relapse rates, by about 50%, reduced the number of brain lesions visible on MRI scans, and lowered the proportion of patients experiencing sustained disability worsening, compared with a placebo.
DECIDE, which included 1,841 participants with RRMS, compared Zinbryta against Avonex (interferon beta-1a), an approved MS therapy, for up to 144 weeks (nearly three years). Results indicated that treatment with Zinbryta significantly lowered — by 45% — the average annual relapse rate, compared with Avonex. MRI measures also favored Zinbryta, but the therapies did not significantly differ in terms of confirmed disability progression.
Last updated: Feb. 10, 2022, by Marisa Wexler MS
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