FDA’s Landmark Approval Paves the Way for Takeda’s Eohilia, Revolutionizing EoE Treatment FDA’s Landmark Approval Paves the Way for Takeda’s Eohilia, Revolutionizing EoE Treatment

Written By Michael Gary Scott

Monday, a monumental milestone was achieved as the FDA greenlit Takeda Pharmaceutical Co Ltd’s groundbreaking oral treatment for eosinophilic esophagitis (EoE). The newly approved Eohilia (budesonide oral suspension) marks a pivotal shift as the first and only FDA-endorsed oral therapy for individuals aged 11 and above grappling with EoE, a persistent and inflammatory condition lodged in the esophagus.

By the end of February, Eohilia, designed as a convenient 2 mg/10 mL single-dose stick pack, will be within reach for those in dire need of relief.

A powerful corticosteroid, Eohilia is intended for a 12-week treatment regimen among patients aged 11 and older battling EoE.

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The FDA’s stamp of approval hinged on the efficacy and safety data from two pivotal studies – Study 1 and Study 2 – involving patients aged 11 to 56 and 11 to 42, respectively.

In Study 1, a remarkable 53.1% of Eohilia patients attained histologic remission, in stark contrast to a meager 1% in the placebo cohort.

Study 2 revealed that 38% of Eohilia patients achieved histologic remission versus a nominal 2.4% in the placebo group.

In both Study 1 and Study 2, the absolute change from baseline in the Dysphagia Symptom Questionnaire (DSQ) combined score in the Eohilia group was significantly higher than that in the placebo group, signifying a substantial leap in patient well-being.

The DSQ, pivotal in evaluating the frequency of swallowing difficulties and subsequent patient adaptations, demonstrated how Eohilia outperformed the placebo, painting a striking picture of its efficacy.

During the concluding two weeks of each study, a significantly higher number of Eohilia recipients experienced minimal or no dysphagia compared to the placebo group.

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However, it is worth noting that Eohilia has not shown evidence of being safe and effective for EoE treatment beyond the 12-week threshold.

Price Action: TAK shares are up 0.25% at $14.27 on the last check Monday.