Novartis announced the trial data of Cosentyx indicated for axial spondyloarthritis. The results of 16-week PREVENT study were announced; the primary endpoint is ASAS40 in patients with active non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx has achieved the primary endpoint and all the secondary endpoints.
Novartis has submitted 16-week data to EMA for the approval of the fourth indication of Cosentyx. The company is planning to submit 52-week data to get the approval from Food and Drug Administration (FDA) in the USA.
The expected approvals are based on PREVENT study, a Phase 3 study. The primary endpoint is the number of patients achieving ASAS40 response at week 16 and week 52. Change in BASDAI and ASDAS-CRP are the secondary endpoints. ASAS40 improved in at least 40% of the patients.
nr-axSpA is associated with chronic inflammatory back pain, nocturnal pain, muscle stiffness, and impaired quality of life.