The European Committee for Medicinal Products for Human Use (CHMP) today announced its positive recommendation for the approval of Enbrel® (etanercept) as a treatment for children aged 8 years and over and adolescents with severe plaque psoriasis. If approved by the European Commission, following the Committee's recommendation, Enbrel will become the first biologic treatment indicated for severe psoriasis in children and adolescents.
Enbrel is currently approved in the European Union for the treatment of moderate-to-severe plaque psoriasis in adults, as well as for ankylosing spondylitis, psoriatic arthritis, moderate to severe rheumatoid arthritis (RA) in adults, and polyarticular juvenile idiopathic arthritis (JIA) in children.(1)
"Psoriasis can be a distressing disease at any age," said Stevo Knezevic, MD, PhD, Chief Medical Officer of Wyeth Europa. "A third of psoriasis patients first see signs of the disease well before the age of 16 and there are currently limited effective treatment options available with approved dosing regimens for children and adolescents. We are, therefore, encouraged by the positive recommendation from the CHMP for the approval of Enbrel® for use in the paediatric population."
The recommendation by the CHMP is based on results from the first randomised placebo-controlled trial of a biologic treatment in children aged 17 and under (study 211). Results from the study showed that patients treated with Enbrel experienced a significant improvement of their plaque psoriasis compared to those treated with placebo. There were no serious adverse events or serious infections during the 12-week placebo-controlled period and rates of adverse events were similar for Enbrel and placebo.
Impact of Psoriasis
Across Europe, 5.1 million people are estimated to have psoriasis(2), a distressing chronic inflammatory disease. Approximately 80 per cent of these patients have plaque psoriasis, which is characterised by red, scaly patches.(3) Psoriasis can be extremely distressing, and may have a significant impact on patients' quality of life. It is a condition which is frequently physically and psychologically disabling.(4)
Currently, treatments for children and adolescents with psoriasis are mainly limited to topical medications that are applied directly to the skin. Whilst these treatments may be effective at reducing the visible skin lesions and associated symptoms, they are generally used for mild and moderate forms of paediatric psoriasis.
Enbrel is an innovative drug that works by reducing the chronic inflammation that leads to plaque psoriasis.