The European Commission (EC) has approved Novartis Cosentyx (secukinumab, formerly known as AIN457) as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Cosentyx (at a dose of 300 mg) is the first and only interleukin-17A (IL-17A) inhibitor to be approved in Europe and this approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients. Currently, all biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and Stelara (ustekinumab) are recommended for second-line systemic therapy in Europe.

"With this groundbreaking news from the European Commission, clear skin may now be a reality for patients living with psoriasis," says David Epstein, Division Head, Novartis Pharmaceuticals. "Nearly half of psoriasis patients are not content with current therapies, including biologic treatments, showing a significant unmet need for patients. Cosentyx, with a first-line systemic indication for treatment of psoriasis will provide patients a better chance of achieving clear or almost clear skin."

The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70 per cent or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52. Data from the Cosentyx clinical trial programme also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life.

The EU approval follows the recent results of the phase IIIb CLEAR study, which showed that Cosentyx was superior to Stelara in clearing skin of patients living with moderate-to-severe plaque psoriasis. The CLEAR study was the second head-to-head study for Cosentyx. Cosentyx also showed superiority to Enbrel (etanercept) in clearing skin in the FIXTURE study. In the phase III clinical programme the overall safety profile of Cosentyx was favourable, with minimal differences seen between etanercept and ustekinumab in head-to-head comparison.

In addition to the EU, Cosentyx has been approved in Australia for the treatment of moderate-to-severe plaque psoriasis and in Japan for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis (PsA).

The US Food and Drug Administration (FDA) decision in moderate-to-severe plaque psoriasis is anticipated early in 2015 following the unanimous recommendation of approval in October 2014 from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US FDA.

Cosentyx is a human monoclonal antibody that selectively neutralises IL-17A. IL-17A is found in high concentrations in skin affected by psoriasis and is a preferred target for investigational therapies. Cosentyx works by inhibiting the action of interleukin-17A (IL-17A), a protein found in high concentrations in skin affected by the disease. In the phase III programme, Cosentyx demonstrated a favourable safety profile, with similar incidence and severity of adverse events between secukinumab treatment arms (300 mg and 150 mg).

Phase IIIb studies in psoriasis are ongoing in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis.

Cosentyx is also in phase III development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS); regulatory applications are planned for 2015.

Psoriasis is a chronic immune-mediated disease characterised by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain; it is associated with significant impairment of physical and psychological quality of life. Psoriasis affects up to 3 per cent of the world's population, or more than 125 million people. In Europe, the estimate is about 0.8 per cent, which means that plaque psoriasis affects about 3.7 million Europeans, with about 2.4 million considered to have moderate-to-severe disease.

This common and distressing condition is not simply a cosmetic problem even people with very mild symptoms are affected everyday. Furthermore, there is an urgent need for new psoriasis treatments, as up to 50 per cent of patients are not content with current therapies, including biologic treatments.