12 March 2025 - Seikagaku announced today that it has received from the US FDA a complete response letter concerning Seikagaku’s biologics license application in the US for SI-6603 (condoliase), a treatment that reduces leg pain associated with lumbar disc herniation.

No concerns about the clinical study results, including the efficacy and safety of SI-6603, were expressed by the FDA, and no additional clinical studies are required.

Read Seikagaku press release