Seikagaku receives FDA response on condoliase application

Seikagaku Corporation (TSE: 4548) announced today that it received a CRL from the FDA on March 11th (U.S. time) concerning its application for SI-6603 (generic name: condoliase). While the FDA did not express concerns regarding the efficacy or safety based on clinical trial results, nor did it request additional clinical trials, it cited areas for improvement related to the manufacturing facilities and the management of the drug substance and product. Seikagaku intends to work closely with Ferring Pharmaceuticals, with whom they have a licensing agreement, to address the FDA’s feedback and resubmit the application as quickly as possible. The impact of this CRL on Seikagaku's consolidated earnings forecast for the fiscal year ending March 2025 is currently under review, and the company will disclose further information should any significant impact be identified.