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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...

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