Takeda (TYO: 4502) and HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) have provided an update on the New Drug Application (NDA) filing for Elunate (fruquintinib) with the US FDA. The FDA has granted the filing priority review status and set a Prescription Drug User Fee Act (PDUFA) date for November 30, 2023.
Rolling NDA Filing and Indication
HutchMed completed a rolling NDA filing for fruquintinib, an inhibitor of the vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, in March of this year. The two companies are seeking the first US indication for metastatic colorectal cancer (CRC) in patients who have been previously treated.
Fruquintinib’s Global Development and Approval History
Developed in-house by HutchMed, fruquintinib was first approved in China in September 2018 as a second-line metastatic CRC treatment. The drug gained national insurance coverage from January 2020. In March 2023, Takeda Pharma entered into a USD 1.13 billion licensing deal for the drug, acquiring global development, manufacturing, and commercialization rights except for mainland China, Hong Kong, and Macau. Eli Lilly holds exclusive commercialization rights to the drug in China.
Confidence in FDA Approval and Global Clinical Development
HutchMed and Takeda are confident in fruquintinib’s potential to gain FDA approval. Dr. Michael Shi, HutchMed’s R&D head and Chief Medical Officer, stated, “The clinical benefit of fruquintinib has been confirmed in multiple ways, from global clinical studies to commercialization in China.” The development of the molecule has been a global effort, with the FRESCO-2 global Phase III trial recruiting over 600 patients from sites in the US, Europe, and Australia.-Fineline Info & Tech
