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European Commission backs LEO Pharma’s Kyntheum

Drug has been approved to treat moderate-to-severe plaque psoriasis

LEO

European regulators have given the go-ahead for LEO Pharma’s Kyntheum (brodalumab) licensing it to treat moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy.

The approval brings about encouraging news for the Denmark-based group, as the drug is the first and only biologic that targets the IL-17 receptor.

Professor Richard Warren, consultant dermatologist of Salford Royal NHS Foundation Trust, said: “Today’s decision by the European Commission is an important milestone for nearly two million people living with psoriasis in the UK, a quarter of whom will have, or may develop, a moderate or severe form of the disease.

“Despite recent advances in treatment, there are still some patients who cannot achieve the complete sustained skin clearance they desire.”

People suffering from plaque psoriasis - the most common type of psoriasis affecting up to 97% of patients - are at an increased risk of developing other conditions such as heart disease and metabolic syndrome.

Christopher Griffiths, foundation chair in dermatology at the University of Manchester, said: “ Psoriasis can have a significant physical and emotional impact on the daily lives of people affected, and can also be linked to several other medical conditions.

“Novel biologic therapies such as brodalumab mean that achieving completely clear skin can now be a reality for people with moderate-to-severe psoriasis.”

The European Commission’s decision comes off the back of LEO’s AMAGINE trials, which showed that 37-44% of patients with plaque psoriasis achieved complete skin clearance at week 12, compared to 19-22% on Johnson & Johnson’s Stelara (ustekinumab).

Additionally, across all three trials, 56-61% of patients reported the skin condition no longer impaired their health-related quality of life after 12 weeks of brodalumab treatment.

Dr Sathish Kolli, medical director at LEO Pharma UK/IE, said: “LEO Pharma has an extensive heritage in Dermatology spanning more than half a century and we are proud to be able to bring a new option forward for prescribers and patients in the area of significant unmet need.”

The announcement follows the approval of brodalumab - marketed as Siliq by Valeant Pharmaceuticals - in the US for the same indication, but has come with a black box warning linking the drug to suicidal thoughts.

Article by
Gemma Jones

3rd August 2017

From: Regulatory

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