Novartis readies FDA app after Cosentyx scores in spondyloarthritis trial

Novartis
Novartis is looking for its fourth indication for blockbuster Cosentyx. (Novartis)

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.

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RELATED: Novartis' Cosentyx chases Eli Lilly's Taltz with new spondyloarthritis data

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.

RELATED: Can new data give Lilly's Taltz one head start on Novartis' Cosentyx?

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.”

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