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.
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.