Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended by the European Medicines Agency’s human medicines committee to treat younger eosinophilic oesophagitis (EoE) patients.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be authorised for use in children aged one to 11 years who weigh at least 15kg and are inadequately controlled by, intolerant to, or are not candidates for conventional medicinal therapy.
If approved by the European Commission, Dupixent would be the first and only medicine in the EU indicated to treat EoE patients in this age group, the companies noted.
The CHMP’s recommendation was supported by positive results from the phase 3 EoE KIDS trial, in which a significantly greater proportion of children receiving Dupixent achieved histological disease remission at week 16 compared to placebo, with results sustained for up to one year.
Improvements in the frequency and severity of EoE signs were also observed in Dupixent-treated patients, and safety results were generally consistent with the known safety profile of the drug in adult and adolscent patients.
EoE is a chronic inflammatory disease that results in a range of symptoms, including difficulty swallowing, vomiting and pain.
Already approved in the EU to treat certain EoE patients aged 12 years and older, Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central drivers of the type 2 inflammation that plays a major role in multiple related diseases.
Beyond EoE, Dupixent holds approvals to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria and chronic obstructive pulmonary disease.
The drug most recently received approval from the US Food and Drug Administration as an add-on maintenance treatment for adolescents with CRSwNP, a chronic disease of the upper airway that obstructs the sinuses and nasal passages.
It was also approved by the Medicines and Healthcare products Regulatory Agency this month as an add-on maintenance treatment for chronic obstructive pulmonary disease.