Kyntheum receives EU approval for treating adults with psoriasis

AstraZeneca and MedImmune announced that LEO Pharma has been granted marketing authorization in all 28 EU member countries plus Iceland, Liechtenstein and Norway for Kyntheum for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

Kyntheum (brodalumab) is the only biologic that selectively targets the interleukin 17 (IL-17) receptor subunit to block the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation, according to a news release.

In July 2016, AstraZeneca granted LEO Pharma exclusive rights to develop and commercialize Kyntheum in Europe. Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab (Siliq), except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co., Ltd.

MedImmune is AstraZeneca’s global biologics research and development arm.

The psoriasis clinical trials program for Kyntheum consisted of three clinical trials; AMAGINE-1 (661 patients), AMAGINE-2 (1,831 patients) and AMAGINE-3 (1,881 patients). Complete skin clearance (Psoriasis Area Severity Index [PASI] 100) was achieved by a higher percentage of patients treated with brodalumab 210 mg compared with patients treated with Stelara (ustekinumab, Janssen) the AMAGINE-2 and AMAGINE-3 trials, according to the release.

In the AMAGINE-1 trial, 83% of patients treated with brodalumab 210 ng achieved PASI 75 compared with 3% of patients treated with placebo at 12 weeks (P < .001).

Data from the three trials found brodalumab to be well tolerated, common adverse events including arthralgia, nasopharyngitis, headache, and upper respiratory tract infection.

There were cases of suicidal ideation and behavior reported, but no causal association between treatment with brodalumab and increased risk of suicidal ideation and behavior has been established, according to the release.

Kyntheum’s European launch will be supported by post-marketing pharmacovigilance activities to follow up on any reports of safety events, AstraZeneca reported.

Reference: www.astrazeneca.com