Posted by Michael Wonder on 19 Sep 2019
Novartis has submitted application to EMA for approval of Cosentyx in nr-axSpA, which would be the fourth indication
17 September 2019 - 52-week data from the PREVENT study, to support FDA submission, are expected later in the year.
Novartis today announced positive new data from the PREVENT trial evaluating the efficacy and safety of Cosentyx (secukinumab) in patients with nr-axSpA (non-radiographic axial spondyloarthritis).
The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 16, showing a significant and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo. The trial demonstrated a favourable safety profile consistent with previous clinical trials.
