Sanofi’s Dupixent could potentially change the treatment paradigm for eosinophilic esophagitis, says GlobalData
Sanofi submitted its Dupixent (dupilumab) data for eosinophilic esophagitis (EoE) to the Food and Drug Administration (FDA) on February 28, just a couple of weeks after the discontinuation of Takeda’s Eohilia (budesonide oral suspension) after it failed to gain an FDA approval. If successful, Dupixent will be the first to market for EoE and will offer challenging competition for other biologics trying to find a position in the market, says GlobalData, a leading data and analytics company.
The Phase III (NCT03633617) data showed that Dupixent significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo in adolescents and adults ages 12 years and older. Additionally, Sanofi announced its plan to file for approval in other countries later this year.
Mandana Emamzadeh, PhD, Healthcare Analyst at GlobalData, comments: “The sale of high-priced Dupixent represents the most impactful driver of growth for the EoE market. GlobalData expects Dupixent to become the market leader with sales of $915.6 million in 2030.”
EoE is a chronic, immune-mediated, atopic, inflammatory condition of the esophagus that has gained recognition over the past two decades. In EoE, eosinophils infiltrate the esophagus, 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).
Emamzadeh continues: “Dupixent, an interleukin 4 receptor subunit alpha inhibitor, is injected subcutaneously once weekly. This is a lower frequency of administration than that of currently available off-label therapies. Although it is a first-in-class drug for EoE, Dupixent is a blockbuster drug for several allergic disorders including eczema, rhinosinusitis, asthma, and atopic dermatitis. Additionally, it is very well known among physicians.”
Dupixent is the only pipeline agent being studied in Phase III (NCT04394351) for a younger population, specifically ages 1–11. This study is expected to launch in Q2 2024. Other pipeline agents in Phase III are Ellodi’s APT-1011, which is expected to launch in Q1 2023 for adults ages 18 years and older and Q1 2024 for adolescents ages 12–17 years; biologics such as Bristol Myers Squibb’s cendakimab (RPC-4046), which is expected to launch in Q2 2024; and AstraZeneca’s Fasenra (benralizumab), which is expected to launch in Q4 2025 for adolescents and adult ages 12 years and older.
Emamzadeh adds: “Key opinion leaders interviewed by GlobalData expected Dupixent to target a small patient population that does not respond to current therapies for EoE. As a result, the launch of Dupixent is not very likely to reduce the use of off-label proton pump inhibitors and corticosteroids in the first and second line, respectively.”