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Cosentyx FDA Approval History

Last updated by Judith Stewart, BPharm on June 30, 2022.

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, Non-Radiographic Axial Spondyloarthritis, Enthesitis-Related Arthritis

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

  • Cosentyx is indicated for the treatment of:
    • moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy
    • active psoriatic arthritis (PsA) in patients 2 years of age and older
    • adults with active ankylosing spondylitis (AS)
    • adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation
    • active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

Development timeline for Cosentyx

Dec 22, 2021Approval Novartis Cosentyx Receives FDA Approval for the Treatment of Children and Adolescents with Enthesitis-Related Arthritis and Psoriatic Arthritis
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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