Cosentyx Receives FDA Approval for New Indication

Novartis announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease spectrum.

“The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with Cosentyx versus placebo,” said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the PREVENT clinical trial. “This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.”

The approval of Cosentyx for nr-axSpA is based on efficacy and safety outcomes from the PREVENT Phase III study, which included 555 adults with active nr-axSpA that were biologic treatment naïve or had an inadequate response / were intolerant to an anti-tumor necrosis factor-α therapy (anti-TNFs). Cosentyx met the primary endpoints achieving statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) response criteria in biologic-naïve individuals at week 52.

nr-axSpA patients treated with Cosentyx showed improvement in both load and without load arms compared to placebo-treated patients at Week 16 in health-related quality of life as measured by the Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire (Least Squares mean change: Week 16: -3.5 and -3.6 -vs -1.8, respectively). General health status and quality of life was assessed by the Short Form health survey (SF-36). At Week 16, patients treated with Cosentyx showed greater improvement from baseline in the SF-36 physical component summary (PCS) score and in the mental component summary (MCS) score10. The safety profile of Cosentyx in the PREVENT trial was shown to be consistent with previous clinical trials. No new safety signals were detected.

nr-axSpA is part of the axSpA spectrum, which is characterized by inflammatory arthritis of the spine associated with chronic inflammatory back pain. The axSpA 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.

“There is a need for additional treatment options. Having a new treatment option for the axSpA community is truly encouraging," said Cassie Shafer, Chief Executive Officer of the Spondylitis Association of America. “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.”

In April 2020, Novartis received European Medicines Agency approval of Cosentyx for the treatment of nr-axSpA15.