Novartis receives FDA approval for Cosentyx® label update to include moderate to severe scalp psoriasis

February 13, 2018  Source: pharma.us.novartis 43

Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis.1 The updated label includes Cosentyx data in moderate to severe scalp psoriasis – one of the difficult-to-treat forms of the disease, which affects approximately half of all psoriasis patients.1-3 The label update is effective in the US immediately, and is based on the proven efficacy and consistent safety profile of Cosentyx from a dedicated Phase III scalp psoriasis trial.6

The updated label for Cosentyx in scalp psoriasis addresses an important unmet need. Scalp psoriasis can be challenging to treat with topical agents or phototherapy due to the presence of hair and other factors.2 Approximately half of all 125 million patients with psoriasis may suffer from scalp psoriasis.2,4

"This is an important label update for Cosentyx, the first IL-17A inhibitor approved for moderate to severe plaque psoriasis. It confirms the additional value Cosentyx offers to patients who seek a treatment effective in various areas of the body," said Eric Hughes, Global Development Unit Head, Immunology & Dermatology. "We're proud to expand treatment possibilities of Cosentyx for an even greater number of patients."

Cosentyx is currently the only fully human IL-17A antagonist to demonstrate efficacy and safety in a dedicated Phase IIIb study of scalp psoriasis.6 The label update is based on 12-week primary endpoint results from the US study of moderate to severe scalp psoriasis patients where Cosentyx (300 mg) demonstrated superior efficacy compared to placebo.1,6

Cosentyx, in a separate study, has demonstrated sustained long-term efficacy, as well as a safety profile consistent with that seen in pivotal trials.7 To date, more than 125,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications since launch.8

About Cosentyx (secukinumab) and IL-17A

Cosentyx, launched in 2015, is the first and only fully-human interleukin-17A (IL-17A) antagonist approved to treat moderate to severe plaque psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).1 By specifically targeting IL-17A, Cosentyx addresses an important cytokine involved in the development of psoriasis.1,9 IL-17A plays a significant role in the pathogenesis of plaque psoriasis, PsA and AS.1,9-11 Inhibiting IL-17A is important as up to 30% of patients with psoriasis may have PsA.12

In psoriasis, Cosentyx delivers long-lasting skin clearance with a sustained response and favorable safety profile out to 5 years, as demonstrated in a clinical study, along with convenient dosing in a patient-friendly auto injector.7,13 Cosentyx has been studied in dedicated trials for the most difficult-to-treat types of plaque psoriasis – palmoplantar psoriasis (psoriasis of the hands and feet), scalp psoriasis, and nail psoriasis.6,14,15

Cosentyx is approved in more than 75 countries for the treatment of moderate to severe plaque psoriasis, which includes the European Union countries, Japan, Switzerland, Australia, the US and Canada. In Europe, Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.5 In the US, Cosentyx is approved as a treatment for moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy (light therapy).1

In addition, Cosentyx is the first IL-17A antagonist approved in more than 65 countries for the treatment of active AS and PsA, which includes the European Union countries and the US. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan.16

About the SCALP study1,6

This study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Cosentyx in 102 patients with moderate to severe scalp psoriasis. Eligible patients were equally randomized to either subcutaneous Cosentyx 300 mg or placebo at Weeks 0, 1, 2 and 3, then every four weeks for 12 weeks. At Week 12, patients in the placebo group who did not achieve at least a 90% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score were switched to Cosentyx 300 mg at weeks 12, 13, 14, 15, 16 and 20 (study completion - 24 weeks). The primary endpoint was the proportion of patients who achieved PSSI 90 response at Week 12. The key secondary objective was Investigator's Global Assessment modified 2011 (IGA) 0 (clear) or 1 (almost clear) response (for the scalp only) at week 12. The proportion of patients achieving an IGA scalp only score of 0 or 1 (clear or almost clear) were 56.9% and 5.9% for Cosentyx and the placebo groups, respectively.

About psoriasis

Psoriasis is a common, non-contagious, auto-immune disease that affects more than 125 million people worldwide.4 Plaque psoriasis is the most common form of the disease and appears as raised, red patches covered with a silvery white build-up of dead skin cells.17

Psoriasis is not simply a cosmetic problem, but a persistent, chronic (long-lasting), and sometimes distressing disease, which can affect even the smallest aspects of people's lives on a daily basis.17 Up to 30% of patients with psoriasis may have PsA.12 PsA is a condition in which the joints are also affected, causing debilitating symptoms including pain, stiffness and for some people, irreversible joint damage.18 Psoriasis is also associated with other serious health conditions, such as diabetes, heart disease and depression.17

By Ddu
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