(CercleFinance.com) – Sanofi announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of its Dupixent in the EU for the treatment of eosinophilic esophagitis in the adult and adolescent.
This favorable opinion extends to people from the age of 12, weighing at least 40 kg, inadequately controlled by a conventional medicine, or who are intolerant to it or do not lend themselves to this type of treatment.
It is based on data from a pivotal trial that showed improved swallowing and histological remission in patients treated with Dupixent 300 mg once weekly compared to placebo.
The European Commission is expected to make its final decision in the coming months. In the European Union, nearly 50,000 adults and adolescents suffer from severe, uncontrolled eosinophilic esophagitis.