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Dupixent (dupilumab), developed by Regeneron Pharmaceuticals in partnership with Sanofi, has received FDA approval for a new indication—treating eosinophilic esophagitis, a chronic inflammatory disease.
On May 20, 2022, Sanofi announced that FDA approved Dupixent (dupilumab) 300 mg weekly to treat eosinophilic esophagitis (EoE) in patients aged 12 years and older who weigh at least 40 kg. According to Sanofi in a company press release, this approval makes Dupixent the first and only medicine specifically indicated to treat EoE in the United States.
A regulatory filing for Dupixent to treat EoE in Europe is under review by the European Medicines Agency, and additional submissions to regulatory authorities in other countries are planned by the end of 2022.
EoE is a chronic inflammatory disease driven by type 2 inflammation, which damages the esophagus and prevents it from working properly. For people with EoE, swallowing can be painful, and they are at risk of choking, even from small amounts of food. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation of the esophagus may be needed. In severe cases, a feeding tube may be the only option. Approximately 160,000 patients in the US suffer from EoE and are currently treated with therapies not specifically approved for the disease. As a result, approximately 48,000 patients continue to experience symptoms despite multiple treatments.
FDA evaluated Dupixent, which was developed by Regeneron Pharmaceuticals in partnership with Sanofi, under priority review and based its approval on data from a Phase III trial with two parts (Part A and Part B) that evaluated the efficacy and safety of Dupixent 300 mg weekly, compared to placebo, in patients aged 12 years and older with EoE and who weighed at least 40 kg. After 24 weeks, patients treated with this dosing schedule experienced 69% and 64% reduction in disease symptoms from baseline in Part A and Part B, respectively. These results compared to 32% and 41% reduction in symptoms in Part A and Part B, respectively. In addition, the safety results were generally consistent with the known safety profile of Dupixent in its approved indications.
Including this newest indication, Dupixent is now approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and EoE.
“We have waited a long time for an FDA-approved treatment option for eosinophilic esophagitis—an underdiagnosed and misunderstood disease of the esophagus that can make it extremely challenging and uncomfortable to eat and swallow. Before today, there were no approved treatments specifically for eosinophilic esophagitis, resulting in many people needing to maintain a strict diet and live in constant fear of food getting stuck in their throat. We welcome therapeutic options that can provide much-needed relief for these patients,” said Mary Jo Strobel, executive director, American Partnership for Eosinophilic Disorders (APFED), in the Sanofi press release.
“Eating regularly throughout the day is essential, yet significant difficulty swallowing food is a common symptom for people living with eosinophilic esophagitis. This can be incredibly upsetting and often leads to fear of pain or choking with every meal, every day. A large unmet need exists for treatment options that can provide meaningful symptom relief. Our Phase [III] clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease. This is a landmark FDA approval for patients and their caregivers who now have a new option for treating this devastating disease,” said John Reed, MD, PhD, global head of Research and Development, Sanofi, in the press release.
“It is gratifying that Dupixent, a medicine that we invented in our laboratories, is now approved in yet another disease marked by allergic or type 2 inflammation, namely eosinophilic esophagitis. Eosinophilic esophagitis can be debilitating for patients, by inflaming and damaging the esophagus and limiting the ability to eat normally. Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the United States, and today’s approval marks the fourth disease for which Dupixent is now indicated, reinforcing the promise of targeting IL [interleukin]-4 and IL-13 to effectively treat diseases with underlying type 2 inflammation,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer, Regeneron, in the press release.