On 28 February, Sanofi submitted its Dupixent (dupilumab) data for oeosinophilic oesophagitis (EoE) to the US Food and Drug Administration (FDA), just a couple of weeks after the discontinuation of Takeda’s Eohilia (budesonide oral suspension) after it failed to gain FDA approval. 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 aged 12 years and older. In addition, Sanofi announced its plan to file for approval in other countries later this year. If successful, Dupixent will be the first to market for EoE.
EoE is a chronic, immune-mediated, atopic, inflammatory condition of the oesophagus that has gained 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).
Dupixent, an interleukin four 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. It is also very well known among physicians. Despite this, key opinion leaders interviewed by GlobalData expect Dupixent to target a small patient population that does not respond to current therapies for EoE.
In addition, Dupixent is the only pipeline agent being studied in Phase III (NCT04394351) for a younger population, specifically patients aged 1–11 years. 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 aged 18 years and older and Q1 2024 for adolescents aged 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 adults aged 12 years and older.
Dupixent’s launch is not very likely to reduce the use of off-label proton pump inhibitors and corticosteroids in the first and second line respectively. It will, however, offer challenging competition for other biologics trying to find a position in the EoE market. 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, reaching sales of $915.6m in 2030.