Cosentyx trial data indicate that the drug is ready to get approval for the fourth indication
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.