cimzia

Name CIMZIA®
Description Cimzia® (certolizumab pegol) is a recombinant, humanised antibody Fab’ fragment against tumour necrosis factor alpha (TNFα) expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Indication

Rheumatoid arthritis 
Cimzia®, in combination with methotrexate (MTX), is indicated for the treatment of moderate to severe, active rheumatoid arthritis (RA) in adult patients when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate, has been inadequate.
Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.


Axial spondyloarthritis

Cimzia® is indicated for the treatment of adult patients with severe active axial spondyloarthritis, comprising:
Ankylosing spondylitis (AS)
Adults with severe active ankylosing spondylitis who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).
Axial spondyloarthritis without radiographic evidence of AS.
Adults with severe active axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and /or MRI, who have had an inadequate response to, or are intolerant to NSAIDs.


Psoriatic arthritis
 

Cimzia®, in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate.
Cimzia® can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

 

Plaque psoriasis

Cimzia® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy

Strengths Cimzia® 200 mg solution for injection in pre-filled syringe
Regulatory Status

FDA approval for Rheumatoid Arthritis indication in May 2009, approval for Axial Spondylarthritis & Psoriatic Arthritis in October 2014 and approval for Psoriasis Indication in May 2018

EMA approval for RA indication in October 2009, approval for Axial Spondylarthritis & Psoriatic Arthritis Indication in October 2013 and approval for Psoriasis Indication in June 2018

Registered in KSA, Kuwait, UAE, Qatar, Bahrain, Oman, Lebanon & Tunisia.

Under registration in Morocco, Algeria & Egypt.

Business Partner UCB