Dupixent ®( dupilumab) late- breaking Phase 3 data presented at UEG Week 2022 showed significant histological absolution of eosinophilic esophagitis( EoE) in children 1 to 11 times old
68 of children on a advanced cure of Dupixent achieved histological complaint absolution at week 16
First and only Phase 3 trial to show positive results in this patient population; presently no approved treatments are specifically indicated for children under 12 times of age with EoE
Data support well- established efficacity and safety profile of Dupixent
Late- breaking positive results from a Phase 3 trial assessing the investigational use of Dupixent ®( dupilumab) in children progressed 1 to 11 times with active eosinophilic esophagitis( EoE) will be presented moment at United European Gastroenterology( UEG) Week 2022. The data will be submitted to nonsupervisory authorities around the world, starting with theU.S. Food and Drug Administration( FDA) in 2023. In May 2022, Dupixent 300 mg weekly was approved by the FDA to treat EoE in people aged 12 times and aged, importing at least 40 kg.
About Eosinophilic Esophagitis
EoE is a habitual seditious complaint that damages the esophagus and prevents it from working duly. The results seen with Dupixent in grown-ups and children with EoE demonstrate that IL- 4 and IL- 13 are crucial and central motorists of the type 2 inflammation underpinning this complaint.
In children, common symptoms of EoE include acid influx, puking, abdominal discomfort, trouble swallowing, and a failure to thrive. These symptoms can impact growth, weight gain and development, and can beget food- related fear and anxiety which can persist through majority. Diet adaptations, which hourly include the elimination of numerous foods, is the standard treatment for EoE, as well as the use of treatments not approved for the complaint in children. These include proton pump impediments, swallowed topical corticosteroids, or in severe cases, a feeding tube, which may be used to insure proper sweet input and weight gain.
About the Dupixent Pediatric Eosinophilic Esophagitis Trial
The Phase 3, randomized, double-eyeless, placebo- controlled trial estimated the efficacity and safety of Dupixent in youthful children progressed 1 to 11 times with EoE, as determined by histological, endoscopic and patient- or caregiver- reported measures. At birth, 98 of these cases had at least oneco-existing type 2 seditious complaint similar as food mislike, antipathetic rhinitis, asthma and atopic dermatitis.
The primary endpoint was histological complaint absolution, which was defined as peak esophageal intraepithelial eosinophil count of ≤ 6 eosinophils( eos)/ high power field( hpf). Secondary endpoints included abnormal endoscopic findings( EoE Endoscopic Reference Score( EoE- EREFS) on a 0- 18 scale), as well as changes in caregiver- reported symptoms( proportion of days with 1 or further EoE signs(e.g., stomach pain, puking, food turndown) by the Pediatric EoE subscribe/ Symptom Questionnaire- caregiver interpretation( PESQ- C)). The PESQ- C is a new endpoint developed by Sanofi and Regeneron used for the first time in this trial, designed to assess symptoms in youthful children through their caregivers( as signs), as children may have difficulty articulating their symptoms themselves. An exploratory endpoint assessed change from birth in body weight for age percentile.
Dupixent is a completely mortal monoclonal antibody that inhibits the signaling of the interleukin- 4( IL- 4) and interleukin- 13( IL- 13) pathways and isn’t an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a drop in type 2 inflammation in Phase 3 trials, establishing that IL- 4 and IL- 13 are crucial and central motorists of the type 2 inflammation that plays a major part in multiple affiliated and frequentlyco-morbid conditions. These conditions include approved suggestions for Dupixent similar as asthma, atopic dermatitis, habitual rhinosinusitis with nasal polyposis( CRSwNP), EoE and prurigo nodularis( PN).
Dupixent has entered nonsupervisory blessings in one or further countries around the world for use in in certain cases with atopic dermatitis, asthma, CRSwNP, EoE or PN in different age populations. Dupixent is presently approved across these suggestions in theU.S. and for one or further of these suggestions in further than 60 countries, including in the European Union and Japan. further than,000 cases have been treated with Dupixent encyclopedically.
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