Certolizumab pegol

Overview

Certolizumab pegol is a pegylated monoclonal antibody against the tumor necrosis factor-alpha (TNF-alpha). It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibody-mediated cytotoxicity as well as to markedly increase its half-life. Certolizumab does not require glycosylation for active function and hence, its production is significantly more affordable when compared to other existing TNF-alpha therapies as it can be done directly in bacterial hosts such as E. coli. It was developed and manufactured by UCB Pharma, first FDA approved in 2008 and updated for a new indication on March 28, 2019.

Indication

Certolizumab pegol has been approved for several different conditions listed below: In Canada, certolizumab pegol is additionally approved in combination with methotrexate for the symptomatic treatment, including major clinical response, and for the reduction of joint damage in adult patients with moderately to severely active rheumatoid arthritis and psoriatic arthritis. Inflammation is a biological response against a potential threat. This response can be normal but in certain conditions, the immune system can attack the body's normal cells or tissues which causes an abnormal inflammation. TNF-alpha has been identified as a key regulator of the inflammatory response. The signaling cascades of this inflammatory mediator can produce a wide range of reactions including cell death, survival, differentiation, proliferation and migration.

Associated Conditions

Moderate to Severe Plaque Psoriasis
Moderately to Severely Active Rheumatoid Arthritis
Non-radiographic Axial Spondyloarthritis
Psoriatic Arthritis
Severe Crohn's Disease
Active Ankylosing spondylitis
Active Psoriatic arthritis
Moderate Crohn’s Disease
Moderate Psoriatic Arthritis
Moderate Rheumatoid arthritis
Severe Psoriatic Arthritis
Severe Rheumatoid arthritis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis	2021/02/05	NCT04740814	Phase 1	Completed	UCB Biopharma SRL
A Study to Test Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Crohn's Disease	2020/11/25	NCT04643483	Phase 3	Withdrawn	UCB Biopharma SRL
Impact of Tapering Immunosuppressants on Maintaining Minimal Disease Activity in Adult Subjects With Psoriatic Arthritis	2020/10/30	NCT04610476	Phase 3	Recruiting	University of Erlangen-Nürnberg Medical School
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis	2019/10/11	NCT04123795	Phase 3	Recruiting	UCB Biopharma SRL
A Study to Assess How Well Certolizumab Pegol Works in Patients With Moderate to Severe Plaque Psoriasis as Part of Routine Clinical Practice	2019/08/13	NCT04053881	N/A	Completed	UCB Biopharma SRL
Named Patient Program With Certolizumab Pegol in Adults Suffering From Rheumatoid Aarthritis (RA)	2018/06/18	NCT03559686	N/A	AVAILABLE	UCB Biopharma SRL
CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)	2018/06/18	NCT03559660	N/A	NO_LONGER_AVAILABLE	UCB Biopharma SRL
A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis	2017/07/12	NCT03215277	Phase 2	Completed	UCB Biopharma SRL
IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy	2017/05/12	NCT03152058	Phase 2	Recruiting	David Ware Branch
Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation	2017/04/04	NCT03100253	Phase 4	Terminated	Mario Negri Institute for Pharmacological Research

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Cimzia	UCB, Inc.	50474-710	SUBCUTANEOUS	200 mg in 1 mL	1/3/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Cimzia	UCB Pharma,Allée de la Recherche 60,B-1070 Bruxelles,Belgium	Authorised	10/1/2009
Cimzia	UCB Pharma,Allée de la Recherche 60,B-1070 Bruxelles,Belgium	Authorised	10/1/2009

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CIMZIA certolizumab pegol (rbe) 200 mg/mL solution for injection - pre-filled pen	281317	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	2/10/2017
CIMZIA certolizumab pegol (rbe) 200 mg/mL solution for Injection - pre-filled syringe	154726	UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia	Medicine	A	1/20/2010

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