Japanese drugmaker Kyowa Kirin (TYO: 4151) today said that it has submitted a supplemental application for Lumicef (brodalumab) for the treatment of axial spondyloarthritis (axSpA) in Japan.
The supplemental application is based on the result of a Phase III clinical trial in patients with axSpA in Japan, South Korea and Taiwan. Lumicef met the primary endpoint, and efficacy and safety in patients with axSpA were confirmed in this study.
"Submitting this application for Lumicef for axial spondyloarthritis is a significant step," said Mitsuo Satoh, executive officer, vice president head of R&D Division of Kyowa Kirin, adding: "We believe that Lumicef has the potential to contribute to the health of patients with axSpA."
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