Partial change approved for Kyowa Kirin's Lumicef in Japan

Japanese mid-size drugmaker Kyowa Kirin (TYO: 4151) says it has received approval from the Ministry of Health, Labor and Welfare (MHLW) for partial change of approved indication of Lumicef (brodalumab [genetical recombination]) for the treatment of palmoplantar pustulosis (PPP) that respond inadequately to existing therapies.

Kyowa Kirin applied for the PPP indication in September last year, based on the results of a Phase III clinical trial of brodalumab in patients with PPP who have had an inadequate response to existing therapies in Japan. Lumicef met the primary endpoint, and efficacy and safety in patients with PPP were confirmed in this study. Phase III clinical trial results have been presented at the Congress of European Academy of Dermatology and Venereology (EADV) in September 2022.

Yoshifumi Torii, 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 PPP patients as a new treatment option with this approval.”