EU Commission approves Kyntheum (brodalumab) of moderate-to-severe plaque psoriasis.- Leo Pharma

AstraZeneca and MedImmune, announced that its partner Leo Pharma has been granted full marketing authorisation in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum (brodalumab), a new biologic medicine developed for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A .By binding to this specific receptor subunit on the cells of the skin, rather than targeting free inflammatory mediators, Kyntheum blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation.

Psoriasis is a common, chronic, immune-mediated inflammatory skin disease affecting an estimated 125 million people worldwide, including nearly 14 million Europeans. It primarily affects the skin, but carries with it a substantial social and psychological burden, even when a relatively small proportion of body surface is affected.

The AMAGINE clinical trial programme (AMAGINE 1-3) involved 4,373 patients with moderate-to-severe psoriasis, the largest study population in the development programme of any new biologic medicine for psoriasis to date.

In July 2016, AstraZeneca announced an agreement granting Leo Pharma, a specialist in dermatology, exclusive rights to develop and commercialise Kyntheum in Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., Ltd. Brodalumab is currently approved in the US (under the brand name Siliq) and in Japan for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.