Belgian pharmaceutical firm UCB has secured approval from the US Food and Drug Administration (FDA) for the use of the drug Cimzia (certolizumab pegol) to treat non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
This marks the first FDA approval for nr-axSpA, which is a type of inflammatory arthritis that primarily affects spine and sacroiliac joints, and often remains undiagnosed or inadequately treated.
Onset of the chronic disorder starts in early adulthood. The condition is characterised by debilitating back pain, stiffness and fatigue. It does not show any visible damage on X-rays.
Cimzia is an Fc-free, PEGylated anti-tumour necrosis factor (TNF) with high affinity for human TNF-alpha. It is designed to selectively neutralise the pathophysiological effects of TNF-alpha.
UCB executive vice-president and Immunology head Emmanuel Caeymaex said: “The FDA approval of CIMZIA for adults with non-radiographic axial spondyloarthritis will be transformative for the many patients living with this disease.”
Cimzia’s approval is based on findings from the Phase III C-AXSPAND clinical trial conducted in a total of 317 adults with non-radiographic axial spondyloarthritis.
Participants in the multi-centre, double-blind, placebo-controlled 52-week trial were administered with the drug or placebo in conjunction with common background medications such as NSAIDs and analgesics.
The trial met its primary endpoint of major improvement response in Ankylosing Spondylitis Disease Activity Score (ASDAS-MI) at week 52. This improvement was observed in 47.2% of subjects receiving the drug, compared to 7% of patients treated with placebo.
It also met a key secondary endpoint, with 47.8% of Cimzia-treated participants experiencing a 40% improvement in Ankylosing Spondylitis Assessment Score (ASAS40) versus 11.4% in case of placebo, at week 12.
Originally approved in 2008, the drug is also indicated for moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS).
It is additionally indicated to treat moderate to severe plaque psoriasis and for mitigating signs and symptoms of Crohn’s disease (CD).