Novartis' Cosentyx heads for fourth indication


Novartis’ Cosentyx could be heading for a fourth indication after the company published late-stage trial data showing it improved symptoms in patients with non-radiographic axial spondyloarthritis (nr-axSpA).

Novartis said the phase 3 PREVENT study met its 16-week primary endpoint by showing an improvement of at least 40%, and at least 10 units on a 0-100 scale, in at least three symptom measures from a list.

The symptoms assessed included a patient global assessment, pain, function, and inflammation such as morning stiffness.

Cosentyx (secukinumab) is already Novartis’ top selling drug, bringing in $858 million in Q2, up around 22% compared with the previous year’s figures.

With this potential new indication in non-radiographic axial spondyloarthritis, these sales could continue to grow.

The PREVENT trial is ongoing and Novartis said a filing with the FDA is planned later in the year if the benefits are still seen after a year’s follow-up.

The European Medicines Agency is already reviewing a dossier, setting up potential European launches towards the end of next year if no issues arise with the regulator.

Novartis hopes that with this indication, Cosentyx will be able to be used across all stages of the disease – it is already approved in the form of the disease where joint damage can be detected using X-rays.

It is also FDA-approved in psoriatic arthritis and plaque psoriasis, and Novartis said the safety profile seen in PREVENT matched up with those seen in previous trials.

PREVENT enrolled 555 male and female adults with non-radiographic axial spondyloarthritis with early onset disease before 45 years of age.

Patients were allocated to three treatment groups – subcutaneous Cosentyx 150 mg with a loading dose taken weekly for four weeks, then a monthly maintenance dose, Cosentyx 150 mg taken monthly without a loading dose, or subcutaneous placebo taken weekly for four weeks followed by a monthly maintenance dose.

While there are numerous drugs on the market that treat autoimmune diseases by turning down the immune system, Cosentyx is the only approved drug that works by inhibiting interleukin-17 (IL-17), an important cytokine involved in inflammation.