Patients with severe plaque psoriasis are a step closer to getting NHS funded access to LEO Pharma’s Kyntheum, after cost regulators published final draft guidelines backing the drug.
LEO Pharma’s Kyntheum (brodalumab) is a novel biologic approved in Europe in July last year, and is the first and only psoriasis treatment to target the L-17 receptor.
By binding to this specific receptor on the cells of the skin, Kyntheum blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation, offering a different mechanism of action to all other psoriasis biologics currently available, which target free inflammatory mediators.
In the clinical trials, 37-44 percent of patients treated with the drug achieved complete skin clearance (PASI 100) at week 12, compared with 19-22 percent with ustekinumab, with “high levels” of skin clearance sustained with continuous brodalumab treatment through week 52.
On the back of these data the National Institute for Health and Care Excellence issued a Final Appraisal Determination rather than an Appraisal Consultation Document (ACD), accelerating the appraisal pathway.
The guidelines back Kyntheum as an option for adults with severe plaque psoriasis who have not responded to standard systemic therapies or who are unable to take them. The endorsement is also contingent upon the provision of the drug at the discount agreed in the terms of a confidential patient access scheme.
“Once this recommendation is implemented, brodalumab, with its differentiated mode of action, will represent a valuable treatment option,” said Professor Richard Warren, consultant dermatologist, North West, Salford Royal NHS Foundation Trust and The University of Manchester.