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Cosentyx FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved January 21, 2015)
Brand name: Cosentyx
Generic name: secukinumab
Dosage form: Injection
Company: Novartis Pharmaceuticals Corporation
Treatment for: Plaque Psoriasis, Ankylosing Spondylitis, Psoriatic Arthritis

Cosentyx (secukinumab) is a selective interleukin-17A (IL-17A) inhibitor for the treatment of plaque psoriasis, ankylosing spondylitis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

Development Timeline for Cosentyx

Jun  1, 2021Approval  Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis
Jun 16, 2020Approval  Cosentyx Receives FDA Approval for New Indication to Treat Active Non-Radiographic Axial Spondyloarthritis
Jan 15, 2016Approval  Novartis Receives FDA Approval for Cosentyx (secukinumab) to Treat Patients with Ankylosing Spondylitis and Psoriatic Arthritis
Jan 21, 2015Approval  FDA Approves Cosentyx (secukinumab) for Plaque Psoriasis
Nov 10, 2014Novartis to present first IL-17A Phase III data for AIN457 (secukinumab) in Psoriatic Arthritis and Ankylosing Spondylitis
Oct 20, 2014FDA Advisory Committee Recommends Approval of Secukinumab for Plaque Psoriasis

Further information

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