Novartis readies FDA app after Cosentyx scores in spondyloarthritis trial

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.

Cambrex Webinar

Understanding the Importance of Crystallization Processes to Avoid Unnecessary Cost, Risk and Development Delays

Wednesday, May 27, 2020 | 10am ET / 7am PT

A well-developed crystallization process can produce suitable particles that can facilitate consistent filtration, drying and formulation of the API and allow confident and reliable manufacturing of the final drug product, while avoiding unnecessary cost, risk and development delays.

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.”

Suggested Articles

BMS' Opdivo and Yervoy only just won their first approval in previously untreated metastatic NSCLC, but the pair is already making it two.

Wrapping up the legal battle at $10 billion would be a win for Bayer, as it has lost $30 billion in market value since the Monsanto buyout.

Takeda’s Alunbrig has arrived in previously untreated, ALK-positive NSCLC. But there’s plenty of competition waiting to greet it at the door.