pharmaphorum February 13, 2024
In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE).
The US regulator has cleared Eohilia (formerly TAK-721), an oral suspension formulation of the well-established steroid drug budesonide, for people 11 years and older with EoE after turning down Takeda’s first attempt in 2021 with a request for an additional clinical trial.
Takeda had hoped that Eohilia would be the first-ever treatment for EoE, but that crown was snatched by Sanofi and Regeneron’s injectable antibody Dupixent (dupilumab), which was approved for the condition in 2022.
Faced with the cost of a second trial, the Japanese drugmaker said after the first rejection it was planning...
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