Months after missing its PDUFA date, FDA slaps down Takeda's old Shire drug for eosinophilic esophagitis
Takeda CEO Christophe Weber thought he had a win in the bag for TAK-721 — one of the experimental drugs spotlighted in the company’s $62 billion Shire acquisition — and went so far as to announce a brand name after snagging priority review last year. But months after missing its PDUFA date, the FDA’s now saying better luck next time.
Regulators handed TAK-721 a complete response letter for the treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus, Takeda revealed on Tuesday. While the pharma company didn’t share much information on the FDA’s reasoning behind the rejection, execs shared that the agency has recommended an additional clinical study “in order to help resolve FDA feedback.”
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