(CercleFinance.com) – Sanofi announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency had issued a favorable opinion on the extension of the indication of Dupixent to the treatment of eosinophilic eophagitis in children.
The pharmaceutical group specifies that this recommendation applies to children aged 12 months to 11 years 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 lead monclonal antibody, was already approved in the European Union for the treatment of eosinophilic esophagitis in certain categories of adults and adolescents aged 12 and over.
It is also approved for many other indications, ranging from atopic dermatitis to asthma, chronic spontaneous urticaria and chronic obstructive pulmonary disease.
More than a million patients are now being treated with this drug worldwide.
Eosinophilic esophagitis is a chronic, progressive disease that affects the esophagus and its function, which can harm a child’s development by compromising their ability to feed, as well as causing vomiting and abdominal pain.
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