(Reuters) -The U.S. health regulator has approved the use of Regeneron and Sanofi’s Dupixent to treat an allergic inflammation of the esophagus in children aged one to 11 years old and weighing at least 15 kg, the companies said on Thursday.
The U.S. Food and Drug Administration in 2022 approved the blockbuster drug for treating eosinophilic esophagitis (EoE) in patients aged 12 years and older, making it the first for the immune condition in the country.
In EoE, white blood cells called eosinophils build up in the esophagus, resulting in damage and inflammation that can impact the ability to eat food.
About 21,000 children below 12 years are being treated for EoE in the U.S. and around 9,000 of those do not respond satisfactorily to unapproved therapies, Sanofi had said in September.
(Reporting by Puyaan Singh, Leroy Leo and Mariam Sunny in Bengaluru; Editing by Sriraj Kalluvila)
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