Regeneron, Sanofi Get FDA OK for Esophagus Inflammation Treatment in Younger Children
By Ben Glickman
Regeneron Pharmaceuticals and Sanofi's Dupilumab received approval from the U.S. Food and Drug Administration for a treatment of an esophagus inflammation condition in younger children.
The pharmaceutical companies, which are jointly developing the monoclonal antibody treatment under a global collaboration agreement, said that the FDA had approved Dupilumab for treating eosinophilic esophagitis, or EoE, in children aged 1 to 11 years weighing at least 15 kg.
The drug was previously approved by the FDA in May 2022 for treating EoE patients aged 12 and older who weigh at least 40 kg.
The treatment is also approved for various other indications, including atopic dermatitis and asthma, in different age populations.
Regeneron and Sanofi said EoE was a chronic disease associated with type 2 inflammation and is believed to be responsible for damaging and limiting the function of the esophagus.
Write to Ben Glickman at ben.glickman@wsj.com
(END) Dow Jones Newswires
January 25, 2024 15:04 ET (20:04 GMT)
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