Novartis’ first-in-class psoriasis drug approved in Europe
Novartis has received final approval from the European Commission for Cosentyx (secukinumab) as a first-line systemic treatment for moderate-to-severe plaque psoriasis, two months after it received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
Cosentyx is the first interleukin-17A (IL-17A) inhibitor approved in Europe, providing a new first-line biologic treatment option for patients and has been shown as superior to Stelara and Enbrel in trials. 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,” said 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.”
In clinical studies, at least 70 per cent of patients achieved clear or almost clear skin during the first 16 weeks of treatment, which was maintained with continued treatment in the majority of patients up to week 52. It is a human monoclonal antibody that selectively neutralises the protein IL-17A, which is found in high concentrations in skin affected by psoriasis.
Cosentyx has also 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 this year.
Phase IIIb studies 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, with regulatory applications planned for 2015.
Psoriasis affects up to 3 per cent of the world’s population, or more than 125 million people.
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