This site is intended for healthcare professionals
Blue test tubes arranged in a line, disappearing into the background
  • Home
  • /
  • News
  • /
  • 2022
  • /
  • 12
  • /
  • Dupixent is recommended for EU approval by the CHM...
News

Dupixent is recommended for EU approval by the CHMP for the treatment of eosinophilic esophagitis.- Regeneron Pharma + Sanofi

Read time: 1 mins
Published: 17th Dec 2022

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE).

This positive opinion covers those who are 12 years and older, weighing at least 40 kg, and inadequately controlled by, are intolerant to or who are not candidates for conventional medicinal therapy.

The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In May 2022, Dupixent 300 mg weekly was approved by the FDA for the treatment of patients aged 12 years and older, weighing at least 40 kg.

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition.

Condition: Eosinophilic Oesophagitis
Type: drug
How do you prefer to access medical updates and information?

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.