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Zinbryta Approval History

  • FDA approved: Yes (First approved May 27th, 2016)
  • Brand name: Zinbryta
  • Generic name: daclizumab
  • Dosage form: Injection
  • Company: AbbVie, Inc. and 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).

The FDA approval of Zinbryta was based primarily on the results of two global, randomized, double-blind clinical trials - the Phase 3 DECIDE Study and the Phase 2b SELECT Study - that involved approximately 2,400 patients with relapsing forms of multiple sclerosis (RMS). In the DECIDE Study, Zinbryta demonstrated a significant reduction in clinical relapses compared to Avonex (interferon beta-1a), and in the SELECT Study, demonstrated a significant reduction in relapses compared to placebo.

Zinbryta is self-administered as a subcutaneous injection once a month. Zinbryta comes with a boxed warning to alert health care professionals and patients of the risk of liver injury, and patients should have regular liver function tests during treatment.

The most common side effects reported during the DECIDE Study include nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, bronchitis, eczema and lymphadenopathy; and during the SELECT Study include upper respiratory tract infection, depression, rash, pharyngitis, and increased alanine aminotransferase (ALT).

Development History and FDA Approval Process for Zinbryta

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

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