The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the drug dupilumab for the treatment of adults and adolescents aged 12+ with Eosinophilic Oesophagitis (EoE).

Dupilumab is the first drug to have been approved in the US for treating EoE and has now completed the review by the European Medical Agency (EMA) for use in the EU. It is the first biologic drug in the EU indicated for EoE and the first treatment approved for age 12+.

Supporting evidence comes from a clinical trial that showed Dupixent^® (dupilumab) improved EoE symptoms and improved disease-specific quality of life. Recently published data from an extension of the trial has shown that the drug maintains its long-term efficacy and safety up to week 52.

As of December 2022, the use of dupilumab in adults and adolescents with EoE is investigational in the EU and is not yet approved - further updates are expected in May 2023.

Update:

The European Commission approved dupilumab for patients aged 12 years and older who weigh at least 40 kg. 

Links

• Press release Sanofi-Regeneron
• Part A of Dupixient Study
• Part C (extension) of Dupixient Study