Novartis Reports Additional Data On Spondylitis Drug Cosentyx
Zacks Investment Research | Oct 02, 2019 10:09PM ET
Novartis AG (NYSE:NVS) announced additional positive data from the ongoing PREVENT study on spondylitis drug, Cosentyx (secukinumab).
PREVENT is an ongoing two-year randomized, double-blind, placebo-controlled phase III study (with a two-year extension phase) investigating the efficacy and safety of Cosentyx in patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
The study met its primary endpoint of ASAS40 at week 52, showing a significant and clinically meaningful reduction in disease activity in patients treated with Cosentyx versus placebo. The study demonstrated a sustained response and a safety profile consistent with previous clinical trials. No new safety signals were detected.
In September, Novartis had released positive 16-week PREVENT data. The study met its primary endpoint at week 16 as the data showed a significant and clinically meaningful reduction in disease activity in patients treated with Cosentyx compared to those on placebo. The study also met all secondary endpoints. Additionally, the data demonstrated a favorable safety profile, consistent with previous clinical studies.
Notably, axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain. nr-axSpA forms part of the axSpA spectrum and is characterized by chronic inflammatory back pain and symptoms such as nocturnal pain, morning stiffness and impaired quality of life. The spectrum includes ankylosing spondylitis (AS), in which joint damage is visible on x-ray, and nr-axSpA, in which joint damage is not visible on x-ray.
Per estimates, approximately 1.7 million patients with nr-axSpA are living in the European Union and the United States.
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A). Novartis has already submitted its application to the EMA for the approval of the same in the nr-axSpA indication. If approved, this will be the fourth indication, for which the drug will be approved in this region. The 52-week data from the PREVENT study should support a potential label expansion of the drug in the United States for this indication.
Novartis’ shares have lost 1.7% in the year so far compared with the Zacks Investment Research
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