The US FDA approves Cimzia for the treatment for patients with nr-axSpA.
Global Banking News-March 29, 2019-The US FDA approves Cimzia for the treatment for patients with nr-axSpA
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Public health agency The US Food and Drug Administration Thursday authorised Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA).
According to the company, 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 agency has granted the approval of Cimzia to UCB.
As there has been no US FDA-approved treatments until now, this is the first time the agency has approved a treatment for nr-axSpA, with objective signs of inflammation.
In conjunction, the efficacy of Cimzia for the treatment of nr-axSpA was studied in the company's randomized clinical trial in 317 adult patients with nr-axSpA with objective signs of inflammation, indicated by elevated C-reactive protein (CRP) levels and/or sacroiliitis (inflammation of the sacroiliac joints) on MRI. The trial measured the improvement response on the Ankylosing Spondylitis Disease Activity Score, a composite scoring system. Responses were greater for patients treated with Cimzia compared to patients treated with placebo. The overall safety profile observed in the Cimzia treatment group was consistent with the known safety profile of Cimzia.
((Distributed via M2 Communications - http://www.m2.com))