Novartis to Seek a Fourth Indication for Secukinumab

Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

The interleukin-17 (IL-17) inhibitor is already approved to treat ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

The ongoing PREVENT trial, a 2-year, randomized, double-blind, placebo-controlled study, enrolled 555 patients with nr-axSpA, and the primary end point was Assessment in SpondyloArthritis International Society criteria for 40% improvement (ASAS40) at weeks 16 and 52.

Patients in this study had been taking at least 2 different nonsteroidal anti-inflammatory agents previously, and some patients had received an anti—tumor necrosis factor (anti-TNF) drug in the past. Patients were randomized to receive 150 mg of secukinumab subcutaneously once per month after 4 weekly induction doses, 150 mg of secukinumab subcutaneously once per month without a loading dose, or placebo. In addition to meeting its primary end point, the trial showed a clinically meaningful reduction in disease activity versus placebo, said the drug maker.

“Non-radiographic axial spondyloarthritis is a chronic debilitating disease, which left untreated can have a significant impact on patients’ quality of life,” said Atul Deodhar, MD, professor of medicine and medical director of Rheumatology Clinics at Oregon Health and Science University, and an investigator in the trial, in a statement. “These positive results indicate a potential new treatment option to help patients experience relief from the signs and symptoms of their disease.”

Novartis has already sought an indication in nr-axSpA in the European Union after having submitted 16-week data to the European Medicines Agency for consideration. Those data, which the drug maker said will be presented at a future scientific congress, show that the trial met its primary end point ASAS40 at week 16.

If secukinumab succeeds in gaining an indication for nr-axSpA, it could compete for an increased share of the inflammatory disease market against an increasing number of US and EU biosimilars, including the recent influx of biosimilar anti-TNF options in the European Union.

It could also see a boost from recent changes to treatment guidelines; in the most recent update to the American College of Rheumatology, the Spondylitis Association of America, and the Spondyloarthritis Research and Treatment Network’s guideline for axial spondyloarthritis, although anti-TNF options are recommended over secukinumab, the guideline recommends treatment with an IL-17 inhibitor among patients who have primary nonresponse to a first anti-TNF agent rather than cycling to other anti-TNFs.