EC approves label update for Novartis psoriatic arthritis drug Cosentyx
The European Commission (EC) has approved a label update for Novartis psoriatic arthritis drug Cosentyx (secukinumab) to include dosing flexibility for treating the condition.
Cosentyx is the first and only fully-human treatment that precisely prevents interleukin-17A (IL-17A), in psoriatic arthritis, which is a chronic, progressive and irreversible disease that causes pain, fatigue, and also activity impairment and significant mobility loss because of structural damage.
The new label update given for the Novartis psoriatic arthritis drug Cosentyx includes dosing flexibility of up to 300mg depending on clinical response that will give clinicians with greater choice for their patients.
The label update approved for the drug also includes 24-week structural data with subcutaneous (sc) regimens demonstrating that it inhibits progression of joint damage in psoriatic arthritis.
Paul Emery – Professor of Rheumatology, Arthritis Research UK and Director Leeds NIHR Biomedical Research Centre, commenting on the label update of Cosentyx, said: “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 said that the label update of Cosentyx is significant as psoriatic arthritis can result in significant mobility loss and irreversible joint damage if treated sub-optimally.
The label update of the Novartis psoriatic arthritis drug was driven by sustained efficacy and consistent safety after up-titration to 300 mg in the disease.
According to Novartis, Cosentyx specifically blocks IL-17A, a cornerstone cytokine, known to play a role in the development of spondyloarthritis and psoriatic disease.
The 24-week structural disease progression data of the Novartis psoriatic arthritis drug Cosentyx are from the FUTURE 5 phase 3 study featuring 996 patients.
In this late-stage trial, nearly 90% of patients treated with Cosentyx 300 mg did not have any radiographic disease progression at 24 weeks.
Eric Hughes – Global Development Unit Head, Immunology, Hepatology and Dermatology, commenting on the label update for the Novartis psoriatic arthritis drug, said “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 label update of Novartis psoriatic arthritis drug Cosentyx applies to all European Union and European Economic Area countries and is effective immediately.