FDA Reconsideration Leads to Approval of Takeda Drug for Rare Esophagus Disorder

Takeda Pharmaceutical has obtained FDA approval for a drug to treat eosinophilic esophagitis, a condition where white blood cells build up in the esophagus, causing inflammation and difficulty swallowing. The drug, Eohilia, is a twice-daily oral corticosteroid suspension and is the first FDA-approved oral treatment option for the condition. This approval comes after the FDA initially turned down Takeda’s application. The drug was developed from the acquisition of Shire and does not require another clinical trial. The prescribing information recommends using the drug for no longer than 12 weeks and warns of potential side effects such as increased risk of infections and effects on the production of adrenal hormones. The company does not anticipate a significant financial impact from the approval.

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