On 3 February, Takeda Pharmaceutical announced, during its quarterly earnings call, the decision to cease further support to launch Eohilia (for patients aged 11 years and older) to the oeosinophilic oesophagitis (EoE) market. Key opinion leaders interviewed by GlobalData were hopeful that this drug would become the first to market but, unfortunately, its journey has come to an end.
EoE is a chronic, immune-mediated, atopic inflammatory condition of the oesophagus, which has gained more recognition over the past two decades. In EoE, eosinophils infiltrate the oesophagus, contributing to tissue damage and chronic inflammation. 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). Takeda’s Eohilia, a reformulation of budesonide for EoE, was the first drug to file for US Food and Drug Administration (FDA) approval in the EoE market. In December, however, 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 the first quarter (Q1) of next year to Q1 2026.
Takeda’s exit from the market opens the field for other manufacturers; currently, Ellodi’s APT-1011, a reformulation of fluticasone propionate for EoE as an oral disintegrating tablet, remains the only corticosteroid pipeline agent in Phase III. It is expected to launch in Q1 2023 for adults aged 18 years and older and Q1 2024 for adolescents aged 12-17 years. Other pipeline agents in Phase III are biologics such as Sanofi/Regeneron’s Dupixent (dupilumab), expected to launch in Q2 2023, Bristol-Myers Squibb’s cendakimab (RPC-4046) in Q2 2024, and AstraZeneca’s Fasenra (benralizumab) in Q4 2025, for adults and adolescents aged 12 years and older. Dupixent (dupilumab) is the only pipeline agent being studied in Phase III for a younger population, patients aged 1-11 years, which is expected to launch in Q2 2024.
The termination of Eohilia’s life cycle will result in the continued use of off-label proton pump inhibitors and corticosteroids in the first and second lines of therapy, respectively, until the likely launch of Ellodi’s APT-1011 next year and in 2024. The termination is not, however, expected to have any impact on biologics targeting a small patient population that is not responding to current therapies. Budesonide remains the most commonly used corticosteroid for EoE in the US, not as a marketed drug but off-label.