Takeda’s decision to cease further support to launch Eohilia (for patients ages 11 years and above) to the eosinophilic esophagitis (EoE) market will result in the continued use of off-label proton pump inhibitors and corticosteroids in the first and second line of therapies. However, the termination of Eohilia is not expected to have any impact on biologics targeting a small patient population not responding to current therapies says GlobalData.

EoE is a chronic, immune-mediated, atopic inflammatory condition of the esophagus, which has gained more recognition over the past two decades. In EoE, eosinophils infiltrate the esophagus, contributing to tissue damage and chronic inflammation.

Mandana Emamzadeh, PhD, Healthcare Analyst at GlobalData, comments: “Key opinion leaders interviewed by the leading data and analytics company were initially hopeful that Takeda’s Eohilia would become the first to market for EoE, but that is no longer the case following its termination. However, Takeda’s exit from the market opens the field for other manufacturers, for example Ellodi’s APT-1011, which is due to be released in in Q1 2023 for adults ages 18 years and above and Q1 2024 for adolescents ages 12-17 years old.”

The current treatment options for EoE patients are off-label symptomatic treatments such as proton pump inhibitors (omeprazole and pantoprazole) and corticosteroids (budesonide and fluticasone propionate). Budesonide remains the most commonly used corticosteroid for EoE in the US, not as a marketed drug but as an off-label.

Takeda’s Eohilia, a reformulation of budesonide for EoE, was the first drug to file for FDA approval in the EoE market. However, in December 2021, Eohilia received a complete response letter (CRL) indicating that the drug could not be approved in its present form and the FDA recommended an additional clinical study for further consideration. As a result, GlobalData assumed that Takeda would have needed three years to conduct an additional trial based on the amount of time from prior trials (NCT02605837; NCT02736409), moving the launch date from Q1 2023 to Q1 2026.

Currently, Ellodi’s APT-1011 a reformulation of fluticasone propionate for EoE as an oral disintegrating tablet, remains the only corticosteroids pipeline agent in Phase III. Other pipeline agents in Phase III are biologics such as Sanofi/Regeneron’s Dupixent (dupilumab), expected to launch Q2 2023, Bristol Myers Squibb’s cendakimab (RPC-4046) in Q2 2024, and AstraZeneca’s Fasenra (benralizumab) in Q4 2025, for adolescents and adult ages 12 years and above. Dupixent (dupilumab) is the only pipeline agent being studied in Phase III for a younger population, ages 1–11 years old which is expected to launch in Q2 2024.

Emamzadeh adds:  “Although the termination of Eohilia brings APT-1011 into focus, it raises concerns about whether APT-1011 will face the same fate as Eohilia or it will be the first marketed drug for EoE.”