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Sanofi/Regeneron’s Dupixent shows significant improvements in paediatric eosinophilic oesophagitis

2024-07-10

临床结果临床3期上市批准

Sanofi and Regeneron’s Dupixent (dupilumab) has demonstrated significant improvements in paediatric patients with eosinophilic oesophagitis (EoE), according to phase 3 results published in the New England Journal of Medicine.

Sanofiing aRegeneronelyDupixent2,dupilumabe in the US, EoE is a chronic inflammatory disease that results in a raneosinophilic oesophagitis (EoE)culty swallowing, vomiting and pain.

Already approved to treat certain EoE patients, DupixenEoEs a fuchronic inflammatory diseasey that inhibits the signalling of the interleukidifficulty swallowingukvomitingL13) painways associated with type 2 inflammation.

The late-stage study compared the EoErapy at a wDupixentered higher or lower dose regimen to placebo in patients aged one to 11 yeinterleukin-4 (IL4)wing interleukin-13 (IL13) period in part A, eligibltype 2 inflammationoned to the 36-week extended active treatment period in part B, in which those in the Dupixent group maintained their dose level and those in the placebo cohort switched to Dupixent.

Results showed that a significantly higher proportion of patients who were treated with a weight-tiered, higher- or lower-dose Dupixent regEoEn achieved histologic remission at week 16 compared to those in the placebo group.Dupixent Dupixent

Patients receiving a higher dose of Dupixent experienced significant improvements in disease severity, as assessed by endoscopiDupixentes, with improvements sustained for up to one year. Those treated with a lower dose experienced improvements that were either comparable or lower than those in the higher dose group.

Dupixent also led to improvements inDupixentight for age percentile by week 16, which were sustained for one year, and safety results from the study were generally consistent with the known safety profile of the therapy in adolescents and adults with EoE.

Dupixentl investigator, Mirna Chehade, the Icahn School of Medicine at Mount Sinai, said the results “reinforce the positive results seen in older patients with EoE and strengthen [the] understanding of IL4 and IL13 as key drivers of the type 2 inflamEoEion underlying this disease.”

Dupixent was approved by the US Food and DrIcahn School of MedicineuaryMount SinaioE in paediatric patients aged one to 11 years and weighing at least 15kg, and EoE therapy is currently under review by tIL4EuropIL13Medicines Agency for thtype 2 inflammation

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