Cimzia FDA Approval History
FDA Approved: Yes (First approved April 22, 2008)
Brand name: Cimzia
Generic name: certolizumab pegol
Dosage form: Injection
Company: UCB, Inc.
Treatment for: Crohn's Disease, Acute, Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis
Cimzia (certolizumab) is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, and non-radiographic axial spondyloarthritis.
Development timeline for Cimzia
| Date | Article |
|---|
| Mar 29, 2019 | Approval FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis |
| May 28, 2018 | Approval UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis |
| Oct 18, 2013 | Approval Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis |
| Sep 30, 2013 | Approval FDA Approves Cimzia for Treatment of Adult Patients with Active Psoriatic Arthritis |
| Jul 24, 2013 | U.S. FDA Arthritis Advisory Committee Votes On Cimzia (certolizumab pegol) For Treatment of Adults with Active Axial Spondyloarthritis, Including Patients with Ankylosing Spondylitis |
| May 13, 2009 | Approval UCB's Cimzia (certolizumab pegol) Approved by the U.S. FDA for Adult Patients Suffering From Moderate to Severe Rheumatoid Arthritis |
| Feb 6, 2009 | UCB's meeting with U.S. FDA defines path forward for Cimzia in rheumatoid arthritis |
| Jan 5, 2009 | UCB Receives Complete Response Letter from U.S. FDA for Use of Cimzia in Rheumatoid Arthritis Patients |
| Apr 22, 2008 | Approval Cimzia Approved in the US for the Treatment of Moderate to Severe
Crohn's Disease |
| Feb 6, 2008 | FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid
Arthritis |
| Mar 23, 2007 | UCB Provides Update on Cimzia for Crohn's Disease and Rheumatoid Arthritis in the US |
| Mar 2, 2006 | UCB Submits Biologics License Application to FDA for New Treatment in Crohn's Disease |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medical Disclaimer
