French pharmaceutical company Sanofi has reported positive data from a Phase III clinical trial of Dupixent (dupilumab) in children aged one to 11 years with eosinophilic oesophagitis (EoE).
The double-blind, placebo-controlled, randomised trial assessed the safety and efficacy of Dupixent for up to 52 weeks.
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Trial data showed that the efficacy and safety profile of the therapy in these children was consistent.
Children who remained on a higher dose of Dupixent and those moving from placebo to a higher dose achieved histological disease remission of 63% and 53%, respectively, after 52 weeks.
A reduction of 0.97 and 0.89 points in disease severity from baseline was observed in children who continued on a higher dose of Dupixent and those switching to a higher dose of the treatment, respectively.
In these groups, respective declines of 4.8 and 3.6 points from baseline in abnormal endoscopic findings were also reported.
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By GlobalDataMount Sinai Icahn School of Medicine Professor of Paediatrics and Medicine Mirna Chehade said: “Dupilumab is the first and only therapeutic approved for adults and adolescents 12 years and older who weigh at least 40kg with EoE.
“Data from this Phase III trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is particularly critical for these children.”
Dupixent is a fully human monoclonal antibody designed to hinder the IL-4 and IL-13 signalling pathways.
Last month, the US Food and Drug Administration accepted a supplemental biologics license application for higher doses of Dupixent in EoE patients aged one to 11 years for priority review.
A decision on the approval is anticipated on 31 January next year.
Earlier this year, Sanofi and ALX Oncology began a clinical trial partnership and supply agreement to evaluate evorpacept with Sarclisa (isatuximab-irfc) and dexamethasone to treat relapsed or refractory multiple myeloma.
