Printer Friendly

Cimzia injection approved by United States Food and Drug Administration.

M2 EQUITYBITES-April 1, 2019-Cimzia injection approved by United States Food and Drug Administration


The United States Food and Drug Administration (FDA) has approved UCB's Cimzia (certolizumab pegol) injection intended for the treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis, with objective signs of inflammation, it was reported on Friday.

The efficacy of the product was studied in a randomised clinical trial in 317 adult patients with non-radiographic axial spondyloarthritis with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI.

Nikolay Nikolov, MD, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA's Center for Drug Evaluation and Research, said, Today's approval of Cimzia fulfils an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now.'

((Comments on this story may be sent to

COPYRIGHT 2019 Normans Media Ltd.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2019 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:M2 EquityBites (EQB)
Date:Apr 1, 2019
Previous Article:Blue Sprig Pediatrics closes acquisition of assets of Tangible Difference Learning Centre.
Next Article:Merck invests EUR130m in Swiss manufacturing site.

Terms of use | Privacy policy | Copyright © 2020 Farlex, Inc. | Feedback | For webmasters