Novartis is gunning for an OK for Cosentyx in non-radiographic axial spondyloarthritis (nr-axSpA), and it’s now got one-year data to make its case to the FDA.
The anti-inflammatory blockbuster nailed the primary endpoint in a phase 3 trial, the Swiss drugmaker reported, showing it could sustain its positive benefits to the 52-week mark when pitted against placebo.
Details are under wraps for now, but the pharma giant will trot them out at a future medical meeting, it said. In the meantime, the company is planning to submit them to the FDA; it’s already turned in an approval application to European regulators.
The data follow close on the heels of Novartis’ 16-week results from the same trial, dubbed Prevent. Last month, the company said Cosentyx had topped placebo at cutting down activity and symptoms of nr-axSpA at 16 weeks of treatment among 555 patients, 90% of whom had never received treatment with a biologic.
At that point, Novartis said it would submit its data to the European Medicines Agency but signaled it would look to the 52-week data to form the basis for an application in the U.S.
With a green light in nr-axSpA, Novartis could bump Cosentyx’s indication tally up to four; the drug is already approved in psoriasis, psoriatic arthritis and ankylosing spondylitis, areas to which it beat its rivals—namely, Eli Lilly’s in-class competitor Taltz.
This time around, though, it may not get a head start on the market. Taltz trumpeted its own phase 3 data in the chronic inflammatory condition back in April, and at the time, then-president of Lilly Bio-Medicines Christi Shaw said the results “support our belief that Taltz could become the first IL-17A antagonist to be approved in the U.S.”