The US FDA approval for Cosentyx is based on the Phase 3 PREVENT trial, which showed efficacy in active non-radiographic axial spondyloarthritis (nr-axSpA)
FDA expands approval for Novartis’ Cosenty to include active nr-axSpA. (Credit: Novartis AG.)
Novartis has received the US Food and Drug Administration (FDA) approval for Cosentyx (secukinumab) to treat active non-radiographic axial spondyloarthritis (nr-axSpA).
Cosentyx is a fully-human biologic designed to directly inhibit interleukin-17A (IL-17A), a cytokine involved in the inflammation and development of psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS) and nr-axSpA.
The US regulatory approval would confirm the efficacy of Cosentyx in addressing the axial spondyloarthritis (axSpA) disease spectrum, said the company.
PREVENT clinical trial investigator Atul Deodhar said: “The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with Cosentyx versus placebo. This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.”
PREVENT is a Phase 3 clinical study that evaluates the efficacy and safety of Cosentyx
The US FDA approval for Cosentyx is based on efficacy and safety outcomes from Phase 3 PREVENT clinical trial. PREVENT is a two-year randomised, double-blind, placebo-controlled Phase 3 clinical study to investigate the efficacy and safety of Cosentyx, in patients with active nr-axSpA.
The nr-axSpA is part of axSpA spectrum, characterised by inflammatory arthritis of the spine associated with chronic inflammatory back pain.
The disease spectrum also includes AS, in which joint damage is visible on x-ray, and nr-axSpA, in which joint damage is generally not visible on x-ray. The physical limitations of axSpA can affect activities of daily living as well as leisure activities causing limitations for patients.
The study enrolled 555 male and female adult patients with active nr-axSpA and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest dose up to four weeks before study start.
In the study, Cosentyx has reached the primary endpoints by achieving statistically significant improvements compared to placebo in the signs and symptoms of nr-axSpA.
Spondylitis Association of America chief executive officer Cassie Shafer said: “There is a need for additional treatment options. Having a new treatment option for the axSpA community is truly encouraging.
“Helping reduce the burden on people living with non-radiographic axial spondyloarthritis by improving symptoms that affect their daily lives remains a critical focus for the SAA.”