OSAKA, Japan & CAMBRIDGE, Mass. - The European Commission (EC) has granted approval to Takeda Pharmaceutical Company (NYSE:TAK) Limited (TSE:4502/NYSE:TAK) for FRUZAQLA (fruquintinib), a novel monotherapy for the treatment of metastatic colorectal cancer (mCRC) in adults. This authorization is specifically for patients who have undergone prior standard therapies and have shown progression or intolerance to other treatments.
This decision, made today, comes after the Committee for Medicinal Products for Human Use (CHMP) recommended approval on April 25, 2024, and follows the U.S. Food and Drug Administration's (FDA) approval on November 8, 2023. FRUZAQLA is the first new targeted therapy for mCRC in the EU in more than a decade that is applicable regardless of the patient's biomarker status.
The approval is based on the positive outcomes of the global Phase 3 FRESCO-2 trial, which demonstrated the drug's consistent benefit across various patient groups and a manageable safety profile. The trial compared FRUZAQLA with best supportive care (BSC) against a placebo plus BSC, meeting all primary and secondary efficacy endpoints. The results were published in The Lancet in June 2023.
FRUZAQLA, an oral inhibitor of all three VEGF receptors, is designed to block tumor angiogenesis with enhanced selectivity, which may allow for high drug exposure and sustained target inhibition. This could enable its use in combination therapies. Takeda has exclusive worldwide rights to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau. In China, fruquintinib has been marketed since November 2018 under the brand name ELUNATE®.
The approval of FRUZAQLA is significant for the mCRC community, offering a new treatment option for patients who have exhausted other therapies. Colorectal cancer is a major global health issue, with over 1.9 million new cases and 900,000 deaths in 2022. It remains the third most prevalent cancer worldwide.
Takeda, a global R&D-driven biopharmaceutical company, is committed to improving patient health and advancing treatment options through its diverse pipeline of therapies. This press release is based on a press release statement and contains forward-looking statements about Takeda's business and the potential of FRUZAQLA, which involve risks and uncertainties that could cause actual results to differ materially from those projected.
In other recent news, Takeda Pharmaceutical Company Limited has announced several significant developments. The company has released long-term data from its Phase 3 ADVANCE-CIDP 3 clinical trial, demonstrating the safety and efficacy of HYQVIA® as a treatment for chronic inflammatory demyelinating polyneuropathy. In addition, Takeda's investigational treatment for narcolepsy type 1, TAK-861, showed positive outcomes in Phase 2b clinical trials, with plans to initiate Phase 3 trials.
The company's Phase 3 clinical trials for soticlestat, an epilepsy drug, yielded mixed results. Though it did not meet its primary endpoints, the drug demonstrated a consistent safety profile and achieved significant results in several secondary measures.
The European Medicines Agency has recommended Takeda's rADAMTS13 for the treatment of congenital Thrombotic Thrombocytopenic Purpura, potentially marking it as the first enzyme replacement therapy in the European Union for this condition.
The U.S. Food and Drug Administration has approved Takeda's ENTYVIO as a maintenance therapy for adults with moderately to severely active Crohn's disease. Furthermore, Takeda's ICLUSIG has been approved in combination with chemotherapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. These are among the recent developments in Takeda's ongoing efforts to advance medical treatments.
InvestingPro Insights
As Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) celebrates the European Commission's approval of FRUZAQLA for metastatic colorectal cancer, investors and analysts are closely monitoring the company's financial health and market performance.
With a robust market capitalization of $39.64 billion, Takeda stands as a significant player in the biopharmaceutical space. The company's commitment to innovation and development is reflected in its substantial revenue of $28.17 billion over the last twelve months as of Q4 2024, marking a steady growth rate of 5.87%.
Investors are particularly attentive to Takeda's attractive price-to-book ratio of 0.87 as of Q4 2024, suggesting that the company's stock could be undervalued compared to its actual net asset value. This metric often attracts value investors seeking potential bargains.
Moreover, the company's dividend yield of 4.67% as of 2024 demonstrates Takeda's ability to generate income for its shareholders, coupled with a consistent dividend growth of 4.44% over the last twelve months.
While Takeda's P/E ratio stands at 43.99, indicating a premium valuation, the adjusted P/E ratio for the last twelve months of Q4 2024 is 23.94, which may present a more favorable picture for investors considering the company's earnings potential. An InvestingPro Tip suggests that such a discrepancy between P/E ratios could signal that market sentiment is catching up to the company's actual earning power.
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