EC approves dosing flexibility for Novartis’s Cosentyx in psoriatic arthritis treatment

The European Commission (EC) has granted Novartis approval for a significant update to the label of its psoriatic arthritis treatment, Cosentyx (secukinumab). This update introduces new dosing flexibility, allowing for administration of up to 300mg based on individual clinical response. This development provides clinicians with enhanced options to tailor treatments for their patients suffering from psoriatic arthritis—a chronic and progressive disease characterized by pain, fatigue, activity impairment, and significant mobility loss due to structural damage.

Cosentyx stands out as the first and only fully-human treatment that targets and prevents interleukin-17A (IL-17A) in psoriatic arthritis. The new label not only provides dosing flexibility but also incorporates new 24-week structural data showing the drug’s effectiveness in preventing joint damage progression. These data were derived from the FUTURE 5 phase 3 study, which involved 996 patients. Notably, nearly 90% of patients treated with Cosentyx 300 mg showed no radiographic progression of the disease at 24 weeks.

Paul Emery, Professor of Rheumatology at Arthritis Research UK and Director of the Leeds NIHR Biomedical Research Centre, commented on the update, noting that “Cosentyx has shown that it can slow the progression of joint damage inflicted by psoriatic arthritis, which can lead to significant mobility loss for patients. The label update allows dosing flexibility up to 300 mg, giving clinicians and patients greater choice in how to target this progressive and debilitating condition, based on individual response to treatment.”

Novartis emphasized the importance of this update, stating that psoriatic arthritis can lead to severe mobility loss and irreversible joint damage if not adequately treated. The decision to update the label was driven by sustained efficacy and safety data supporting the up-titration to 300 mg.

Eric Hughes, Global Development Unit Head for Immunology, Hepatology, and Dermatology at Novartis, added, “Cosentyx is the only IL-17A inhibitor to demonstrate 5-year safety and efficacy in Phase III studies of PsA and AS. We are reimagining the well-being of patients living with all facets of psoriatic arthritis. This label update further supports prescribing doctors and patients in their treatment choice.”

The revised label for Cosentyx is now effective across all European Union and European Economic Area countries, marking a crucial step in enhancing treatment options for patients with psoriatic arthritis.