Explosive Dupixent launch suggests Sanofi and Regeneron are digging into their next money mountain

Have Sanofi and Regeneron done it again? After birthing a blockbuster eczema market with the launch of Dupixent, the partners have now seemingly repeated the trick with an eosinophilic esophagitis (EoE) rollout that is going gangbusters and likely still has several years of competition-free growth to come.

That is the takeaway from a report by Spherix, which based the conclusions on its tracking of the launch in EoE and a poll of 125 gastroenterologists and allergists. The FDA approved Dupixent in EoE, an allergic condition of the esophagus, 11 months ago. According to Spherix, “data from March reveals Dupixent use tripling since its launch.”

Spherix’s analysis of the launch of Dupixent in EoE chimes with Regeneron’s recent comments on the indication. Speaking at an event last month, Marion McCourt, executive vice president of commercial at Regeneron, said “there's been thousands of patients who've been treated with Dupixent already for eosinophilic esophagitis” and identified an anticipated pediatric launch as a trigger for further growth. 

Regeneron cited the launch of Dupixent in adults with EoE as a contributor to the 42% growth it achieved in the fourth quarter. At that time, McCourt told investors the EoE launch was “going exceptionally well.”

Spherix’s analysis suggests Sanofi and Regeneron are still a long way off hitting the ceiling for growth in EoE. Based on physician caseload data, the research business estimates that the EoE market is half the size of the inflammatory bowel disease sector. Given the polled physicians estimate nearly half of EoE patients are undiagnosed, there is scope for the market to grow significantly beyond its current size.

Sanofi and Regeneron are in a prime position to translate that growth into Dupixent sales. The survey shows Dupixent is going down well with gastroenterologists and allergists, most of whom see the drug as a moderate to substantial advance over earlier treatments and express a high degree of satisfaction with the product in EoE.

Even so, physicians remain hungry for additional treatment options, with nearly all respondents saying the unmet need for treating EoE remains high. Gastroenterologists and allergists are split on the types of new therapy that are needed, with the former slightly favoring steroids and the latter hoping for fresh biologics. 

Physicians may have to wait years for new treatment options. Two leading challengers flamed out last year, when Takeda dropped TAK-721 in the wake of a complete response letter and AstraZeneca reported that Fasenra failed to address swallowing difficulties in a phase 3 trial. 

The blows to AstraZeneca and Takeda left Bristol Myers Squibb’s cendakimab and Ellodi Pharmaceuticals’ APT-1011 as the front-runners to challenge Dupixent in EoE. BMS’ global phase 3 efficacy study has a primary completion date of May 2024, while Ellodi’s second phase 3 trial is scheduled to pass that milestone shortly after in September 2024.

While those companies try to collect data to support approval, Sanofi and Regeneron have a window in which to try to establish Dupixent as the treatment of choice in EoE. The partners enjoyed a five-year head start in atopic dermatitis, an advantage they used to rack up blockbuster sales while expanding into younger patient populations and launching a prefilled pen to make self-administration more convenient. Now, the race is on to ensure history repeats itself.