Swiss pharmaceutical firm Novartis has secured the European Commission (EC) approval for  Cosentyx (secukinumab) to treat adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

Along with Ankylosing Spondylitis (AS), nr-axSpA is a part of Axial Spondyloarthritis (axSpA), a spectrum of a long-term inflammatory disease characterised by chronic inflammatory back pain.

Novartis global development unit head Eric Hughes said: “Whether a patient has nr-axSpA or AS, the condition has a significant impact on their everyday life.

“We, therefore, welcome the news that Cosentyx has gained approval for the treatment of this form of axial spondyloarthritis because it enables patients to realize relief from their symptoms earlier in the spectrum of disease.

“This is a firm demonstration of our commitment to reimagine medicine for patients and a step forward in our plans to expand Cosentyx across ten indications over the next ten years.”

Cosentyx is the first and only fully-human biologic that directly inhibits IL-17A

Novartis said that Cosentyx is the first and only fully-human biologic that directly inhibits IL-17A, a cornerstone cytokine that induces inflammation and development of PsO, PsA and AS9-12.

The regulatory approval for Cosentyx is based on data from the Phase 3 PREVENT clinical trial, which is an ongoing two-year randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of Cosentyx, in patients with active nr-axSpA.

The study has enrolled 555 male and female adult patients with active nr-axSpA and who were at least on two different non-steroidal anti-inflammatory drugs (NSAIDs) before the study and has reached its primary endpoint.

The proportion of patients achieving an ASAS40 response with Cosentyx 150 mg at Weeks 16 and 52 in TNF-naive patients is the primary endpoint and the change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) are the secondary endpoints.

PREVENT clinical trial investigator Atul Deodhar said: “This approval of Cosentyx for non-radiographic axial spondyloarthritis means clinicians across Europe now have an effective new treatment option to help patients gain relief from the burden of this painful, debilitating disease and achieve a better quality of life both at home and at work.”