Novartis, has announced that the European Commission (EC) has approved a label update for Cosentyx ® (secukinumab).
Cosentyx is the first and only fully-human treatment that specifically inhibits interleukin-17A (IL-17A), in psoriatic arthritis (PsA). The new label update includes dosing flexibility of up to 300 mg based on clinical response that will provide clinicians with greater choice for their patients.
The label update for Cosentyx also includes 24-week structural data with subcutaneous (sc) regimens demonstrating that Cosentyx inhibits progression of joint damage in PsA.
This label update is significant as PsA can lead to significant mobility loss and irreversible joint damage if sub-optimally-treated. PsA is a chronic, progressive and irreversible disease leading to pain, fatigue, as well as activity impairment and significant mobility loss due to structural damage.
The label update for Cosentyx is based on sustained efficacy and consistent safety following up-titration to 300 mg in PsA. Cosentyx specifically inhibits IL-17A – a cornerstone cytokine involved in the development of spondyloarthritis and psoriatic disease. The 24-week structural disease progression data are from FUTURE 5, the largest Phase III study for a biologic conducted in PsA to date (996 patients). In this study, almost 90% of patients treated with Cosentyx 300 mg had no radiographic disease progression at 24 weeks.
Psoriatic arthrtis is a condition for which they are a number of current treatments, Xeljanz® has received marketing authorisation in the EU for psoriatic arthritis while NICE has also recommend Ixekizumab (Taltz®▼) for treating psoriatic arthritis
The label update for Cosentyx is applicable to all European Union and European Economic Area countries and is effective immediately. To date, Cosentyx has been prescribed to more than 160,000 patients worldwide.
Paul Emery Professor of Rheumatology, Arthritis Research UK and Director Leeds NIHR Biomedical Research Centre 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.”
Eric Hughes, Global Development Unit Head, Immunology, Hepatology and Dermatology 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 re-imagining 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.”