Novartis stacks more positive PhIII data on Cosentyx franchise — eyeing approval in non-radiographic axial spondyloarthritis
Days ago Novartis posted a brief note on positive 16-week data about Cosentyx’s effects on non-radiographic axial spondyloarthritis, opening the door to an EMA submission in the indication. Now the pharma giant says it has the 52-week win needed to take to FDA regulators, too.
The new update puts Novartis’ blockbuster IL-17A drug on par with Eli Lilly’s rival therapy, Taltz, for which similar results were reported in April. Both drugs are already approved for another type of spondyloarthritis, but this particular form of inflammatory arthritis does not show visible evidence of damage on X-rays.
In the Phase III PREVENT trial, Novartis investigators wanted to measure the proportion of patients achieving an ASAS40 response — characterized by at least 40% improvement in patient global assessment, pain, function, and inflammation — versus placebo. Cosentyx notched a clear win both at the 16-week and 52-week time points, while also hitting all the secondary goals including other scores.
An OK for nr-axSpA would mark the fourth indication for Cosentyx and extend its reach to a patient population of up to 1.7 million patients in the US and EU.
“These data are encouraging for people living with nr-axSpA, where there are only limited treatment options available,” John Tsai, head of global drug development, said in a statement. “It’s a great example of how we’re working to reimagine medicine to help patients realize early relief from this disease.”
It is also an example of Novartis’ aggressive development plans for a growing drug franchise that brought in $1.65 billion in the first half of the year, fending off rivals in a competitive field. Aside from Taltz, Valeant is pushing Siliq — which targets IL-17RA — while J&J has its own IL-23 drug, Tremfya, for plaque psoriasis. Cosentyx is also marketed as a treatment for ankylosing spondylitis and psoriatic arthritis.