Regulatory Affairs

Leo Pharma gets EC nod for psoriasis treatment Kyntheum

PBR Staff Writer Published 21 July 2017

AstraZeneca’s subsidiary MedImmune announced that its partner Leo Pharma has secured approval from the European Commission (EC) for its Kyntheum (brodalumab) to treat moderate-to-severe plaque psoriasis.

The approval allows to market Kyntheum in all 28 European Union (EU) member countries, as well as Iceland, Liechtenstein and Norway.

Kyntheum is a new biologic medicine developed to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy. It is claimed to be the only biologic that selectively targets the IL-17 receptor subunit A.

It effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, by binding to the receptor with high affinity.

Psoriasis is a chronic and immune-mediated inflammatory skin disease affecting around 125 million people across the globe, including about 14 million Europeans.

In July 2016, AstraZeneca entered into an agreement with Leo Pharma to develop and commercialise Kyntheum in Europe.

Outside of Europe, Valeant Pharmaceuticals had secured commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin.

Currently, brodalumab was approved in the US and Japan for adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

The psoriasis clinical trials program for Kyntheum included three clinical trials, comprising of Amagine-1 with 661 patients, Amagine-2 with 1831 patients and Amagine-3 with 1881 patients.

According to AstraZeneca, data from the three randomized and controlled Amagine clinical trials determined Kyntheum was well tolerated with an acceptable safety profile.

Leo Pharma president and CEO Gitte Pugholm Aabo said: “Those most affected by psoriasis often feel controlled by their condition, the stigma it brings, and the diverse complications associated with it.

“We hope that the EU approval of Kyntheum will help many more people to regain control, and live lives unrestricted by psoriasis, while our role is to support them throughout their journey to clear skin.”

Image: Head office of the European Commission. Photo: courtesy of Amio Cajander.