Posted by Michael Wonder on 28 Oct 2018
Novartis receives approval for Cosentyx label update in Europe to include dosing flexibility in psoriatic arthritis
26 October 2018 - New Cosentyx (secukinumab) label to include dosing flexibility up to 300 mg, based on clinical response, and 24-week structural data with subcutaneous regimens.
Novartis, a leader in immuno-dermatology and rheumatology, announced today 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 is based on Cosentyx 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.
