Novartis Cosentyx gets EU nod to treat active non-radiographic axial spondyloarthritis

Basel: Novartis has announced the European Commission (EC) has approved Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

"This approval of Cosentyx for non-radiographic axial spondyloarthritis means clinicians across Europe now have an effective new treatment option to help patients gain relief from the burden of this painful, debilitating disease and achieve a better quality of life both at home and at work," said Atul Deodhar, MD, Professor of Medicine and Medical Director of Rheumatology Clinics at Oregon Health & Science University, USA, and an investigator in the PREVENT clinical trial.

The approval is based on data from the Phase III PREVENT study, in which Cosentyx met the primary endpoint. In the study, 41.5% of nr-axSpA patients treated with Cosentyx 150 mg showing a significant and clinically meaningful reduction in disease activity versus placebo (41.5% vs 29.2%: p<0.05), as measured by at least a 40% improvement in ASAS40 at week 165, with improvements continued through week 52. Statistically significant improvements in secondary endpoints were also demonstrated, including pain, disease burden and health-related quality of life. PREVENT is the largest ever study of a biologic in patients with nr-axSpA5.