The Food and Drug Administration (FDA) has approved Cimzia (certolizumab pegol; UCB) injection for the treatment of adults with non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, the first treatment approved for this condition.
The approval was supported by data from the phase 3 C-AXSPAND randomized trial (N=317) of adults with nr-axSpA with objective signs of inflammation, as evident by elevated C-reactive protein (CRP) levels and/or sacroiliitis on MRI. The study evaluated improvement of response on the Ankylosing Spondylitis Disease Activity Score.
The data showed a greater response among Cimzia-treated patients vs those who received placebo. The overall safety profile in the Cimzia group was consistent with the known safety profile.
Cimzia, a tumor necrosis factor (TNF) blocker, is already approved to treat adults with Crohn’s disease, moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis (AS), and moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
It carries a Boxed Warning describing the increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis (infection in the blood steam), invasive fungal infections (such as histoplasmosis, an infection that affects the lungs), and other infections. The warning also states that lymphoma and other malignancies have also been reported in children and adolescents who have been treated with TNF blockers.
Cimzia is available as a 200mg/mL solution or powder (after reconstitution) for subcutaneous (SC) injection.
For more information call (800) 234-5535 or visit FDA.gov.