MHLW approval of Lumicef for palmoplantar pustulosis in Japan – Kyowa Kirin

Kyowa Kirin Co., Ltd. announces that the company has received approval from the Ministry of Health, Labour and Welfare (“MHLW”) for partial change of approved indication of Lumicef [KHK4827, generic name: brodalumab (genetical recombination)]for the treatment of palmoplantar pustulosis that respond inadequately to existing therapies.

Lumicef is a fully human anti-interleukin-17 (IL-17) receptor A antibody that inhibits biological activity of inflammatory cytokines such as IL-17A, IL-17A/F, IL-17F, IL-17C by binding to IL-17A receptor selectively. Lumicef is the first IL-17 pathway inhibitor approved in palmoplantar pustulosis.

This approval is based on the results of a Phase III clinical trial of brodalumab in patients with palmoplantar pustulosis who have had an inadequate response to existing therapies in Japan. Lumicef met the primary endpoint, and efficacy and safety in patients with palmoplantar pustulosis were confirmed in this study. In September 2022, Kyowa Kirin filed an application for partial change of approved indication of Lumicef. Phase III clinical trial results have been presented at the Congress of European Academy of Dermatology and Venereology (EADV) in September 2022 and will be presented at the Annual Meeting of the Japanese Society of Psoriasis Research in August 2023.

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin said, “Because the conspicuousness, the pain and itchiness with palmoplantar symptoms, and arthralgia interfere with daily life, new therapeutic treatments are desired to improve their quality of life. We are pleased that Lumicef will contribute to palmoplantar pustulosis patients as a new treatment option with this approval.