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Takeda announced its FY2023 full year results, showing +5.9% revenue growth at AER and +1.5% at CER, with a -13.3% core operating profit change at CER due to generic impact and R&D investment. The company aims for a 100-250 basis points core operating profit margin improvement each year from FY2025. Takeda's financial performance exceeded expectations, with three new therapy approvals from the U.S. FDA in FY2023 and up to six NMEs in phase 3 development in FY2024. The company plans to implement an efficiency program in FY2024 to drive organizational agility, procurement savings, and leverage data, digital, and technology capabilities.
Takeda (NYSE:TAK) has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of fruquintinib, a targeted therapy for previously treated metastatic colorectal cancer (mCRC). If approved by the European Commission, fruquintinib will be a novel treatment in the EU, highlighting its status as the first therapy to inhibit all three vascular endothelial growth factor receptors (VEGFR-1, -2, -3) for mCRC in over a decade. The therapy showed significant improvements in overall survival and progression-free survival in Phase 3 FRESCO-2 trials compared to the current standard care.
Fruquintinib's potential impacts are substantial, offering a new chemotherapy-free option that improves patient outcomes. It has already been approved in the U.S. under the brand name FRUZAQLA® as of November 2023, and launched in China in 2018 as ELUNATE®. Key safety information includes risks such as hypertension, hemorrhagic events, infections, and hepatotoxicity among others.