FDA approval of Takeda Eohilia signals growing opportunities in eosinophilic esophagitis, says GlobalData

The recent approval of Takeda’s Eohilia (budesonide oral suspension) for patients 11 years of age and older, by the US FDA presents an opportunity for the company to compete against Sanofi‘s Dupixent, with potential to capture market share from the latter in the EoE landscape. However, ongoing research is necessary to evaluate its efficacy across different age groups, reflecting the evolving complexities and opportunities within the EoE sector, says GlobalData, a leading data and analytics company.

Takeda’s Eohilia is now the only competitor of Sanofi’s Dupixent, that was once the only approved therapy against EoE in the US. Nevertheless, Sanofi’s Dupixent is the only approved therapy for EoE in patients 11 years old and below, and therefore Takeda’s Eohilia will have to prove efficacy in this age group in future studies.

Interestingly, it needs to be noted that the EoE landscape may be further saturated by other pipeline agents that are currently in late-stage clinical trials, with these companies also standing a chance to acquire further market share from Takeda and Sanofi in the EoE field. These potential entries may further impact the size of the EoE treatment market positively, highlighting opportunities in the field.

Filippos Maniatis, Healthcare Analyst at GlobalData, comments: “Eohilia’s approval marks a significant achievement for the Japan-based pharmaceutical company in the field of EoE. The US now has two drugs for the treatment of EoE, which is exciting for the patients as it may address unmet needs that Sanofi’s Dupixent could not address, such as the problems arising from the subcutaneous administration of Dupixent.”

As of today, Takeda’s Eohilia is the only oral therapy approved for patients of 11 years old and above, in the US, maintaining a competitive advantage over Sanofi’s Dupixent subcutaneous therapy, with studies highlighting the increased preference of patients choosing oral over subcutaneous therapies. However, Dupixent’s approval also includes use of this therapy in the pediatric population (1-11 years old), compared with Takeda’s Eohilia, highlighting the former’s use for a wider patient population.

Maniatis adds: “Although Takeda’s Eohilia have received approval for adolescents and adults, it is yet to show its efficacy in the pediatric population. Sanofi’s Dupixent still holds this advantage over Eohilia, and therefore we may need to wait to see what the future holds for the two pharmaceutical drugs in the field of EoE.”

In addition to the marketed therapies, other pipeline agents are currently in late-stage clinical trials for the treatment of EoE. Specifically, GlobalData’s Pharma Intelligence Center identifies multiple pharmaceutical companies having pipeline agents against EoE, including Bristol Myers Squibb’s intravenous cendakimab, and Ellodi Pharmaceuticals’ oral fluticasone propionate, both of which are under Phase III clinical trials for EoE in the US.

Maniatis concludes: “Upon potential approval of these pipeline agents, the size of the EoE treatment market may further increase, which highlights the opportunities in the field of EoE.”

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