Regeneron: CHMP Recommends Dupixent For EU Approval To Treat Eosinophilic Esophagitis
Regeneron Pharmaceuticals Inc. (REGN) and French drug major Sanofi (SNY) announced Friday that the European Medicines Agency’s Committee for Medicinal Products for Human Use or CHMP has recommended the approval of Dupixent (dupilumab) in the European Union to treat adults and adolescents with eosinophilic esophagitis or EoE.
CHMP’s positive opinion covers those who are 12 years and older, weighing at least 40 kg, and inadequately controlled by, are intolerant to or who are not candidates for conventional medicinal therapy.
The European Commission is expected to announce a final decision on the Dupixent application in the coming months.
If approved, Dupixent would be the first and only targeted medicine specifically indicated for people aged 12 years and older with EoE in the EU.
In May 2022, the U.S. Food and Drug Administration approved Dupixent 300 mg weekly for the treatment of patients aged 12 years and older, weighing at least 40 kg.
EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience.
The companies noted that the CHMP’s positive opinion is based on pivotal trial data demonstrating patients on Dupixent 300 mg weekly experienced significantly improved ability to swallow and achieved histological disease remission compared to placebo.
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