Novartis eyes potential new indication for Cosentyx

Novartis has revealed encouraging results for Cosentyx (secukinumab) as a treatment for axial spondyloarthritis, and is chasing approval in this indication off the back of the data. 

The new data comes from the Swiss pharma’s PREVENT trial, in patients with non-radiographic axial spondyloarthritis (nr-axSpA). The phase 3 trial, which is still ongoing, met its primary endpoint of ASAS40 at week 16, and demonstrated a significant reduction in disease activity when compared to placebo.

The form of the disease which Cosentyx is being studied in, nr-axSpA, can be difficult to diagnose as the joint damage is not visible on x-ray. It is characterised by chronic inflammatory back pain, and if untreated, can significantly impact day-to-day activity.

“These study results for Cosentyx build on our long-standing experience in ankylosing spondylitis and are a step toward a new treatment option that could allow patients to realize relief much earlier in axial spondyloarthritis,” said John Tsai (pictured below), head of global drug development and chief medical officer at Novartis.

John Tsai

“If approved, this would be the fourth indication for Cosentyx,” he added.

The drug, which is already bringing in impressive sales for Novartis, is also approved for another form of this condition, called ankylosing spondylitis, in which joint damage is visible on x-ray. It is also approved for the treatment of psoriatic arthritis and psoriasis.

Cosentyx works by inhibiting IL-17A, a cytokine which is involved in inflammation and the development of these diseases.

The drug grew 25% to $858m in the first half of 2019, and is well on its way to becoming a billion dollar-plus treatment.

However, the inflammatory and immunology field is also becoming increasingly competitive thanks to a new class of biologic therapies which are competing for market share.

This includes Johnson & Johnson’s Tremfya (guselkumab), AbbVie’s Skyrizi (risankizumab), Eli Lilly’s Taltz (ixekizumab) and Pfizer’s Xeljanz (tofacitinib citrate).

According to Novartis, the detailed data from the study will be presented at an as yet unidentified future scientific congress. It has also already submitted a marketing application to the European Medicines Agency for approval in nr-axSpA, and will use the 52 week data from the PREVENT study to support an FDA submission towards the end of the year.