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Taltz FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

FDA Approved: Yes (First approved March 22, 2016)
Brand name: Taltz
Generic name: ixekizumab
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis

Taltz (ixekizumab) is a humanized interleukin-17A antagonist indicated for the treatment of:

  • patients aged 6 years or older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
  • adults with active psoriatic arthritis.
  • adults with active ankylosing spondylitis.
  • adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation.

Development Timeline for Taltz

Jun  1, 2020Approval  Lilly's Taltz (ixekizumab) is the First IL-17A Antagonist to Receive U.S. FDA Approval for the Treatment of Non-Radiographic Axial Spondyloarthritis (nr-axSpA)
Mar 30, 2020Approval  Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis
Aug 26, 2019Approval  FDA Approves Taltz (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
May 22, 2018Approval  Lilly's Taltz (ixekizumab) Receives the First U.S. FDA Approval for Label Update to Include Data for Psoriasis Involving the Genital Area
Dec  1, 2017Approval  Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis
Mar 22, 2016Approval  FDA Approves Taltz (ixekizumab) for Plaque Psoriasis

Further information

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