Sanofi: new positive opinion for Dupixent in EU

(CercleFinance.com) - Sanofi announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had issued a positive opinion on the extension of the indication for Dupixent to the treatment of eosinophilic esophagitis in children.


The pharmaceutical group specifies that this recommendation applies to children aged 12 months to 11 years and weighing at least 15 kg, in the event of failure, contraindication or intolerance to conventional drug treatments.

The European Commission is expected to announce its final decision in the coming months.

Dupixent, Sanofi's flagship monclonal antibody, was already approved in the European Union for the treatment of eosinophilic esophagitis in certain categories of adults and adolescents over the age of 12.

It is also approved for numerous other indications, ranging from atopic dermatitis and asthma to chronic spontaneous urticaria and chronic obstructive pulmonary disease.

Over a million patients worldwide are now treated with the drug.

Eosinophilic esophagitis is a chronic progressive disease that alters the esophagus and its function, which can impair a child's development by compromising his or her ability to eat, while causing vomiting and abdominal pain.


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