Pharma Focus Europe

European Approval Granted to Novartis' Cosentyx® as the First and Only IL-17A Inhibitor for Hidradenitis Suppurativa

Friday, June 02, 2023

Novartis has announced that the European Commission (EC) has approved Cosentyx® (secukinumab) for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults who have not responded well to conventional systemic HS therapy. This approval provides an alternative treatment option for patients with HS, aiming to alleviate physical symptoms, reduce emotional burden, and potentially avoid invasive surgery.

Professor Christos C. Zouboulis, President of the European Hidradenitis Suppurativa Foundation, expressed the urgent need for alternative treatments to address the disabling physical symptoms of HS, improve emotional well-being, and minimize the need for invasive surgical interventions. He welcomed
the expanded approval of Cosentyx as an effective and familiar treatment option for this complex and challenging disease.

Haseeb Ahmad, President Europe at Novartis, emphasized the significance of bringing Cosentyx to HS patients, providing rapid and sustained relief from symptoms. Novartis aims to ensure broad access to Cosentyx with its established market presence and patient support programs. The approval in Europe marks a major milestone, and Novartis awaits a regulatory decision from the US Food and Drug Administration later this year.The approval of Cosentyx for HS was based on the results of the SUNSHINE and SUNRISE trials, which were the largest Phase III program conducted for HS. These trials enrolled over 1,000 patients across 40 countries and evaluated the short-term (16 weeks) and long-term (up to 52 weeks) efficacy, safety, and tolerability of Cosentyx. The results, published in The Lancet, demonstrated that the treatment response rates in patients receiving Cosentyx continued to improve beyond the primary endpoint analysis at Week 16, with over 55% of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 52. The safety profile of Cosentyx was consistent with its use in other indications.

Cosentyx is a fully human biologic that directly inhibits interleukin-17A, a cytokine involved in the inflammation of various conditions, including HS. It is already approved for the treatment of psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis. Cosentyx has a robust clinical foundation with more than 14 years of study and five years of clinical data supporting its long-term safety and efficacy across different indications. It has been used to treat over 1 million patients worldwide.

Hidradenitis suppurativa is a chronic and progressive inflammatory skin disease characterized by recurring boil-like abscesses that can lead to open wounds and irreversible scarring, often in sensitive areas of the body. Diagnosis of HS can be delayed, and there is currently only one approved biologic treatment available, with some patients experiencing a loss of response over time. In advanced cases, surgical intervention is often considered, resulting in additional scarring. HS significantly impacts patients' quality of life and is associated with comorbidities such as obesity, diabetes, arthritis, and depression.

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