The expansion comes off the back of data from the Phase III C-AXSPAND study involving 317 adults with nr-axSpA and objective signs of inflammation.
Top-line results released in 2018 showed that the therapy met the primary endpoint, with 47.2% of Cimzia-treated patients achieving major improvement compared to 7% of those dosed with placebo.
The approval of Cimzia "fulfills an unmet need for patients suffering from non-radiographic axial spondyloarthritis as there has been no FDA-approved treatments until now," said Nikolay Nikolov, associate director for rheumatology of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Nr-axSpA is a type of inflammatory arthritis that causes inflammation in the spine and other symptoms. There is no visible damage seen on x-rays, so it is referred to as non-radiographic.
The label was already expanded last year to include adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, although it was originally approved in 2008 for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis and active ankylosing spondylitis.
Register as Visitor to CPhI China 2019!
-----------------------------------------------------------------------
Editor's Note:
To apply for becoming a contributor of En-CPhI.cn,
welcome to send your CV and sample works to us,
Email: Julia.Zhang@ubmsinoexpo.com.
(All Rights Reserved)