Novartis novel psoriasis treatment gains positive opinion in Europe

Novartis’ Cosentyx (secukinumab) is the first IL-17A inhibitor to receive a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) as a first-line systemic treatment for moderate-to-severe plaque psoriasis.

The first-in-class therapy works by blocking the interleukin protein IL-17A, found in high concentrations in psoriasis-affected skin and had greater efficacy than Pfizer’s existing treatment Enbrel (etanercept), when tested head-to-head in the FIXTURE study. Currently, all other biologic treatments for psoriasis, including anti-tumour necrosis factor therapies (anti-TNFs) and Janssen’s Stelara (ustekinumab), are recommended for second-line use.

David Epstein, division head, Novartis Pharmaceuticals, said, “With this exciting news, we may change the way psoriasis is treated, as 50 per cent of patients are unhappy with their current psoriasis therapies, demonstrating an urgent need for new treatments that clear skin faster and for a longer time.”

In clinical studies, 70 per cent or more patients achieved clear skin or almost clear skin with secukinumab during the first 16 weeks of treatment.

Helen McAteer, chief executive of the Psoriasis Association said, “This is great news for people living with severe psoriasis as it is a potential new treatment option available to them. Psoriasis is so much more than just a skin condition; it is a serious, chronic, inflammatory disease which is associated with numerous co-morbidities and really impacts on the lives of those living with it. This new treatment acts on a specific target, which is thought to play a significant role in the disease, and in doing so has been shown to clear the skin to a high degree. This will bring new hope for many people with psoriasis, those who may have given up treating psoriasis in the past, and for people not achieving satisfactory results with their current therapy.”

The CHMP opinion was based on these positive results and follows the recommendation of approval in October from the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the US Food and Drug Administration. A final decision from the European Commission is expected within two months.

Phase IIIb studies in psoriasis are ongoing, including the head-to-head CLEAR study of secukinumab versus Stelara in moderate-to-severe plaque psoriasis and studies in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis.

Strong rivals in the IL-17 class are Amgen and AstraZeneca’s brodalumab, which has outperformed Stelara in a phase III trial in plaque psoriasis, and Lilly’s ixekizumab, which also produced winning results in a phase III head-to-head with Enbrel and placebo in plaque psoriasis.

Secukinumab is also in phase III development for psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with regulatory applications in these arthritic conditions planned for 2015.


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