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Budesonide CRL Another Setback For Takeda’s ‘Wave 1’ Pipeline

 
• By Ian Haydock

Setback for company's near-term launch goals and US patients with rare esophageal inflammatory condition as regulator asks for additional clinical data. 

esophagitis
US FDA Decides Not To Approve First Drug For Eosinophilic Esophagitis • Source: Alamy

Takeda Pharmaceutical Co. Ltd. has received a Complete Response Letter (CRL) from the US Food and Drug Administration for its 2020 new drug application for Eohilia (TAK-721), an oral suspension of the corticosteroid budesonide for eosinophilic esophagitis (EoE).

The decision marks another setback for one of the most advanced products in the major Japanese firm’s “Wave 1” pipeline of near-term assets, a portfolio of 12 new molecular entities...

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