Corporate Banner
Satellite Banner
Immunology
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

UCB Receives CHMP Positive Opinion for Cimzia in Active PsA

Published: Monday, October 28, 2013
Last Updated: Monday, October 28, 2013
Bookmark and Share
Positive opinion is supported by data from the RAPID™-PsA study.

UCB has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending extending the European Union marketing authorization for the use of Cimzia® (certolizumab pegol) in the treatment of adult patients with active psoriatic arthritis (PsA).

PsA is a chronic, inflammatory condition that causes pain, swelling and stiffness in and around the joints and tendons and usually occurs in combination with psoriasis. In most people with PsA, psoriasis develops before joint problems.

When hands and feet are affected in PsA, nail changes can occur as well as swelling in the fingers and toes (dactylitis). PsA affects an estimated 24 in 10,000 people and affects up to 30% of psoriasis patients. It usually occurs between the ages of 30 and 50.

The long-term burden of PsA is substantial with over half of patients developing progressive, erosive disease with functional impairment.

“This CHMP positive opinion for Cimzia® in active PsA closely follows the European approval of Cimzia® for the treatment of adults with severe active axial spondyloarthritis and illustrates our commitment to the wider population of people in Europe with rheumatology conditions who need innovative, new treatment options,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.

Dr. Loew-Friedrich continued, “Results from the RAPID™- PsA study supporting the positive opinion showed that treatment with Cimzia® improved the clinical signs and symptoms of PsA, including arthritis, enthesitis, dactylitis and skin involvement, with a rapid onset of action.”

The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately two months.

The positive opinion follows the EMA’s review of data from the RAPID™-PsA study, an on-going, Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of certolizumab pegol in patients with adult onset active and progressive PsA.

In the European Union, certolizumab pegol is approved in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs, including MTX.

Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

In addition the European Commission has recently approved certolizumab pegol for the treatment of adult patients with severe active axial spondyloarthritis (axSpA) comprising (1) Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs); (2) Axial spondyloarthritis without radiographic evidence of AS - adults with severe active axSpA 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.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

UCB and Sanofi Partner for Innovation in Immune-Mediated Diseases
Goal is to identify novel small molecule therapies to address a wide range of immune-mediated diseases.
Friday, March 14, 2014
Multimillion Pound Investment in UK Life Sciences Research and Development
UCB invests over £3 million in new bespoke cutting-edge robotic platform for UK R&D HQ.
Wednesday, December 11, 2013
Vectura and UCB to Collaborate and Share Expertise in Severe Inflammatory
Collaboration for the development of an innovative biologic immunomodulatory product in the area of severe inflammatory.
Tuesday, October 01, 2013
UCB Announces Third Research Collaboration with Harvard University
New Research Alliance project to focus on human microbiome to develop new therapeutic applications in immunology.
Wednesday, October 10, 2012
UCB to Showcase Immunology Portfolio at EULAR 2012
Data to be presented on certolizumab pegol, epratuzumab and CDP7851/AMG 785.
Thursday, July 05, 2012
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Researchers Find a Gap in the Brain’s Firewall Against Parkinson’s Disease
Researchers at NIH have found mouse study that identified a key player in the progression of the disorder.
Faecal Bacteria Linked to Body Fat
Researchers at King’s College London have found a new link between the diversity of bacteria in human poo – known as the human faecal microbiome - and levels of abdominal body fat.
‘Cellbots’ Chase Down Cancer, Deliver Drugs Directly to Tumors
Programmable T cells shown to be versatile, precise, and powerful in lab studies.
Anti-Inflammatory Drugs Could Strengthen Airway Immunity
Mold toxins can weaken the airways' clearing mechanisms and immunity, but PKC inhibitors showed promise as a treatment.
Antibodies Paving the Way to HIV Vaccine
Researchers uncover factors responsible for the formation of broadly neutralizing HIV antibodies in humans.
Vaccine Against Common Cold Achievable
Researchers suggest that a vaccine against rhinoviruses is possible using variant virus vaccines.
Iron Nanoparticles Make Immune Cells Attack Cancer
Researchers accidentally discover that nanoparticles invented for anemia treatment can trigger the immune system’s ability to destroy tumor cells.
Uncovering Cancer’s ‘Invisibility Cloak’
Researchers discover cancer cell mechanism to become invisible to the body's immune system.
Treating Sepsis with Marine Mitochondria
Mitochondrial alternative oxidase from a marine animal combats bacterial sepsis.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!