European Commission approves Cosentyx for the treatment of patients with active non-radiographic axial spondyloarthritis (nr-axSpA).- Novartis

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).

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-axSpA.

Novartis is working closely with all stakeholders to ensure that eligible European patients can start benefiting from Cosentyx as quickly as possible. Novartis has also submitted Cosentyx for review by the FDA and the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adults with nr-axSpA.