The U.S. Food and Drug Administration (FDA) recently approved Takeda’s Eohilia, marking the introduction of the first oral medication for eosinophilic esophagitis (EoE) in the United States. EoE is a condition characterized by the inflammation of the esophagus, which can lead to symptoms such as vomiting, difficulty swallowing, and pain. This approval represents a significant milestone for Takeda, especially considering the drug’s journey, which included a period of abandonment following a complete response letter from the FDA.
Eohilia, an oral suspension of budesonide, is approved as a 12-week treatment for patients aged 11 years and older, offering a new therapeutic option for this patient group. This positions Eohilia in direct competition with Sanofi and Regeneron’s Dupixent, an already established treatment for EoE in patients aged 12 and older that received expanded approval in 2022.
The FDA’s approval of Eohilia was based on the results from two Phase II clinical trials, wherein patients with EoE were administered 2 mg of Eohilia twice daily for 12 weeks. The outcomes demonstrated significant improvements in esophagus inflammation and reduced swallowing difficulties in the final two weeks of treatment.
Takeda’s path to securing FDA approval for Eohilia was fraught with challenges. After acquiring the drug through its $62 billion acquisition of Shire, Takeda initially faced a setback in 2021 when the FDA rejected it, requesting an additional clinical trial. The drug, previously known as TAK-721, was briefly abandoned by Takeda following this rejection. Nevertheless, Takeda revisited the drug, addressing the FDA’s concerns in a resubmitted application last September, leading to the drug’s eventual approval. Eohilia is expected to be available by the end of the month, providing a new treatment option for those suffering from EoE.
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[Source: Endpoints, February 12th, 2024]