Secukinumab Expands Label in EU, Approved to Increase Dosing in Treatment of PsA

This week, Novartis announced that the European Commission (EC) approved a label update for secukinumab, sold as Cosentyx. Secukinumab is a targeted biologic therapy for the treatment of psoriatic arthritis (PsA) that inhibits IL-17A, a cytokine involved in inflammation of entheses.

According to Novartis, the label update is significant, as PsA can lead to mobility loss and irreversible joint damage if not treated properly. PsA is a chronic, progressive disease that leads to pain and fatigue as well as activity impairment and significant mobility loss due to structural damage.

“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,” said Paul Emery, professor of rheumatology at the University of Leeds in the United Kingdom.

The update includes dosing flexibility of up to 300 mg based on clinical response that will provide clinicians with dosing flexibility, as well as 24-week structural disease progression data with subcutaneous regimens demonstrating that secukinumab inhibits the progression of joint damage in PsA.

The trial, FUTURE 5, is the largest phase 3 study for a biologic conducted in PsA to date, with an enrollment of 996 patients. The study found that nearly 90% of patients treated with 300 mg of secukinumab had no radiographic disease progression at 24 weeks.

“Cosentyx is the only IL-17A inhibitor to demonstrate a 5-year safety and efficacy in phase 3 studies of PsA and [ankylosing spondylitis]. We are reimagining the well-being of patients living with all facets of psoriatic arthritis,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology, and Dermatology.

The updated label applies to all European Union and European Economic Area countries and takes effect immediately.

Secukinumab’s growing number of indications and its body of positive data may help it to compete for a substantial share of the inflammatory disease market against an increasing number of US- and EU-approved biosimilars, including 4 recently launched adalimumab biosimilars in the European Union.