Sanofi and Regeneron receive FDA approval for eosinophilic oesophagitis treatment

Sanofi and Regeneron have received approval from the US Food and Drug Administration (FDA) for the use of Dupixent (dupilumab) as a treatment for patients with eosinophilic oesophagitis (EoE).

The drug has been approved for use as a 300mg weekly treatment for patients aged 12 years and older with EoE.

The Dupixent application was assessed by the FDA under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

Following the FDA’s decision, Dupixent has become the first and only available medicine specifically recommended for the treatment of EoE in the US.

The approval is based on a phase 3 randomised, double-blind, placebo-controlled trial that assessed the effectiveness and safety of Dupixent in patients aged 12 years and older with EoE.

The weekly dosing schedule of 300mg showed a significant improvement in the signs and symptoms of EoE, when compared to placebo.

EoE is a chronic inflammatory disease driven by type 2 inflammation, with around 160,000 patients  living with the condition in the US. It damages the oesophagus, preventing regular function, and for patients living with the condition, swallowing even small amounts of food can be painful.

Mary Jo Strobel, executive director, American Partnership for Eosinophilic Disorders (APFED) said: “We have waited a long time for an FDA-approved treatment option for eosinophilic oesophagitis – an underdiagnosed and misunderstood disease of the oesophagus that can make it extremely challenging and uncomfortable to eat and swallow.”

Strobel added: “Before today, there were no approved treatments specifically for eosinophilic oesophagitis, 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.”

John Reed, global head of R&D, Sanofi, said: “Our phase 3 clinical programme showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the oesophagus, 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.”

The European Medicines Agency is currently reviewing a regulatory filing for EoE, with further submissions to regulatory authorities in other countries scheduled by the end of 2022.