Cimzia 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 History and FDA Approval Process for Cimzia
|Mar 29, 2019|| FDA Approves Cimzia (certolizumab pegol) for the Treatment for Non-Radiographic Axial Spondyloarthritis|
|May 28, 2018|| UCB Announces the Approval of Cimzia (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis|
|Oct 18, 2013|| Cimzia Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis|
|Sep 30, 2013|| 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|| 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|| Cimzia Approved in the US for the Treatment of Moderate to Severe
|Feb 6, 2008||FDA Agrees to Review Cimzia File for the Treatment of Rheumatoid
|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|
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