Takeda Pharmaceutical Co. Ltd. still has plenty of shots on goal with its Wave 1 pipeline of new molecular entities and label expansion efforts, but the Phase III failure of pevonedistat in high-risk myelodysplastic syndromes or two types of leukemia is another setback for its hyped R&D reorganization strategy this year. The Japanese pharma announced on 1 September that the NEDD-8 activating enzyme inhibitor failed to meet a predefined measure of statistical significance for event-free survival in the Phase III PANTHER trial.
In 2019, Takeda pointed to 12 NMEs in its development pipeline – including pevonedistat – that it said could reach market by 2024, with aggregate sales potential in the $10bn range. (Also see "Takeda Looks To Ride 'Wave 1' To JPY5tn Target" - Scrip, 9 December, 2020.) However, a US Food and Drug Administration action date for eosinophilic esophagitis candidate Eohilia (TAK-721) was missed on 15 April and the filing is still pending at the agency, while the European Medicines Agency later downgraded the review status of TAK-003, a quadrivalent Dengue fever vaccine, from accelerated assessment to standard assessment