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

  • Writer: ipharmaservices
    ipharmaservices
  • Sep 18, 2019
  • 1 min read

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.



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