Novartis Eyes New Cosentyx Approval After Positive Axial Spondyloarthritis Trial


Novartis Cosentyx hit the mark in treating patients with non-radiographic axial spondyloarthritis (nr-axSpA). In a Phase III trial, Cosentyx showed a significant and clinically meaningful reduction in disease activity for patients versus placebo.

Data from the Phase III PREVENT trial showed that Cosentyx (secukinumab) demonstrated a sustained response and maintained a consistent safety profile at 52 weeks. At the end of a year, treatment with Cosentyx met its primary endpoint of ASAS40, a typical measurement for the disease. As Novartis noted, ASAS40 is achieved when there is a measure of an improvement of at least 40% and an improvement of at least 10 units on a 0–100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function according to the Bath Ankylosing Spondylitis Functional Index, and Inflammation.

There are approximately 1.7 million patients with nr-axSpA in the United States and European Union, Novartis said.

No new safety signals were detected, the Swiss pharma giant announced Wednesday. Positive 16-week PREVENT data were announced in the middle of September and submitted to European Medicines Agency for approval in nr-axSpA. The company intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration for Cosentyx in nr-axSpA. The data from the PREVENT trial add to the five-years of clinical data posted last year supporting the long-term efficacy and safety of Cosentyx across ankylosing spondylitis, psoriatic arthritis and psoriasis, the company said.

Full data from the PREVENT trial will be presented at a future medical conference, Novartis said. Cosentyx is an interleukin-17A (IL-17A) inhibitor. IL-17A is produced by various cells from both the innate immune system (which can be triggered by mechanical stress) and the adaptive immune system. Cosentyx has been approved to treat plaque psoriasis, active psoriatic arthritis and ankylosing spondylitis, a form of arthritis that affects the spine.

John Tsai, Novartis’ chief medical officer and head of global drug development, said the data from the PREVENT trial are encouraging for people living with nr-axSpA, a chronic form of arthritis that typically affects the low back and buttocks, which has limited treatment options.

“It's a great example of how we're working to reimagine medicine to help patients realize early relief from this disease,” Tsai said in a brief statement.

Atul Deodhar, medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the secukinumab clinical trial program, said that if left untreated, axial spondyloarthritis can have a significant negative impact on quality of life. The positive results from the PREVENT trial show that Cosentyx could be a potential new treatment option for these patients.

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