The injectable treatment can reduce symptoms and encourage histological disease remission
The European Commission (EC) has approved a medication for eosinophilic esophagitis (EoE), jointly developed by pharmaceutical companies Sanofi and Regeneron.
“This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union,” said Regeneron president and chief scientific officer Dr George Yancopoulos.
The medication, Dupixent, is designed for patients at least 12 years of age and weighing at least 40kg who do not respond effectively to traditional therapies.
EoE is a chronic, progressive inflammatory disease that damages the oesophagus, leading to symptoms such as dysphagia, chest pain and regurgitation. Interleukin-4 (IL-4) and interleukin-13 (IL-13) are key drivers of the type two inflammation underlying EoE. In the EU, about 50,000 adults and adolescents live with severe uncontrolled EoE.
“The impact of EoE on a patient’s daily life cannot be overstated – the narrowing and scarring of the esophagus can make something as simple as eating a painful and distressing experience, and may lead to choking and food impaction,” said Sanofi head of global development, immunology and inflammation Dr Naimish Patel.
Dupixent is an injection administered under the skin at three different injection sites. The injection is available as both a pre-filled pen and a pre-filled syringe at a dose of 300mg administered per week.
Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.
“We remain committed to investigating Dupixent’s potential in additional diseases in which IL-4 and IL-13 may play a key role,” added Yancopoulos.
The EC decision was supported by data from a three-phase trial, where 60% of patients on a 300mg weekly Dupixent treatment experienced a higher rate of histological disease remission. They also experience significant improvements in swallowing-related pain and health-related quality of life.
The safety profile remained consistent throughout the 52 weeks of the trial.
