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Sanofi/Regeneron’s Dupixent approved by EC for eosinophilic oesophagitis

This makes Dupixent the first and only targeted medicine indicated for this condition


Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the European Commission as the first and only targeted medicine for eosinophilic oesophagitis (EoE), the companies announced.

Specifically, Dupixent is indicated for adult and adolescent patients aged 12 years and older, weighing at least 40kg and who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

The companies’ application was supported by 52-week data from a phase 3 trial consisting of three parts.

Dupixent patients in parts A and B of the trial, which compared a weekly 300mg dose of the medicine to placebo for 24 weeks, experienced an approximately ten times higher rate of histological disease remission.

Reduction in disease symptoms and abnormal endoscopic findings were also observed in the first two parts, as well as significant improvements in swallowing-related pain and health-related quality of life less frequent non-swallowing symptoms.

Similar longer term efficacy results were seen in part C, which observed patients who had continued on or switched to Dupixent from the previous two parts for an additional 28 weeks.

EoE is a chronic inflammatory disease that damages the oesophagus and prevents it from working properly. Symptoms vary between patients, especially in those of different ages, but the condition is mostly characterised by vomiting, stomach or chest pain, difficulty swallowing, and food getting stuck in the throat.

Diet adjustment is the standard treatment for EoE, as well as the use of treatments such as proton pump inhibitors, swallowed topical corticosteroids and, in severe cases, a feeding tube to ensure proper caloric intake.

Dupixent, which is now approved to treat five diseases with underlying type 2 inflammation in the EU, is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown to be central to type 2 inflammation.

Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: “The impact of EoE on a patient’s daily life cannot be overstated – the narrowing and scarring of the oesophagus can make something as simple as eating a painful and distressing experience, and may lead to choking and food impaction.

“With this latest approval for Dupixent, adults and adolescents in the EU suffering from the chronic and often debilitating symptoms of EoE now have the first and only targeted treatment option clinically proven to reduce both oesophageal inflammation and damage, as well as improve swallowing ability, pain and health-related quality of life.”

Article by
Emily Kimber

31st January 2023

From: Regulatory



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