UCB Inflammatory Arthritis Treatment Approved

FDA has approved UCB’s Cimzia (certolizumab pegol) injection for treating adults with non-radiographic axial spondyloarthritis, with objective signs of inflammation. An agency news release says this is the first approved treatment for this condition.

Cimzia’s efficacy was studied in a trial of 317 adult patients with objective signs of inflammation, indicated by elevated C-reactive protein levels and/or sacroiliitis on MRI. Cimiza’s labeling includes a Boxed Warning about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, invasive fungal infection, and other infections.

The drug was first approved in 2008 and is also indicated for adult patients with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active ankylosing spondylitis, and moderate-to-severe plaque psoriasis who are candidates for system therapy or phototherapy.