Novartis Cosentyx gets USFDA nod to treat active non-radiographic axial spondyloarthritis
Cosentyx met the primary endpoint 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 5210.;
East Hanover: Novartis has announced that 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 who 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 endpoint 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 5210.
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