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Zinbryta Approval History

FDA Approved: Yes (First approved May 27, 2016)
Brand name: Zinbryta
Generic name: daclizumab
Dosage form: Injection
Company: Biogen
Treatment for: Multiple Sclerosis

Zinbryta (daclizumab) is an interleukin-2 receptor blocking antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS).

In March 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of Zinbryta for the treatment of relapsing multiple sclerosis.

Development History and FDA Approval Process for Zinbryta

Mar  2, 2018Biogen and AbbVie Announce the Voluntary Worldwide Withdrawal of Marketing Authorizations for Zinbryta (daclizumab) for Relapsing Multiple Sclerosis
May 28, 2016Approval FDA Approves Zinbryta (daclizumab) to Treat Multiple Sclerosis
Apr 29, 2015FDA Accepts BLA for Zinbryta (Daclizumab High-Yield Process) for Treatment of MS
Aug  9, 2011Biogen Idec and Abbott Announce Positive Top-Line Results from the First Registrational Trial for Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis
Feb 16, 2010Daclizumab Shows Potential For New Immunoregulatory Approach To Treating Multiple Sclerosis, According To Data Published In The Lancet Neurology
Oct 12, 2007Phase 2 Data Show Daclizumab Significantly Reduced MultipleSclerosis Lesions in Patients Receiving Interferon Beta Therapy
Mar 12, 2007Primary Endpoint Met in Phase 2 Trial of Daclizumab in PatientsWith Relapsing Multiple Sclerosis

Further information

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