Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the European Commission (EC) to treat eosinophilic oesophagitis (EoE) in young patients.
The drug has been specifically 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.
Dupixent, which is already approved by the regulator to treat EoE in patients aged 12 years and older, is now the first and only medicine in the EU indicated for use in this younger patient population.
EoE is a chronic inflammatory disease that results in a range of symptoms, including difficulty swallowing, vomiting and pain.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on positive results from the phase 3 EoE KIDS trial, in which 68% of children aged one to 11 years receiving Dupixent achieved histological disease remission at week 16 compared to 3% in the placebo group, with results sustained for up to one year.
Dupixent demonstrated an 86% reduction in peak oesophageal intraepithelial eosinophil count from baseline compared to a 21% increase for placebo, and showed reductions in abnormal endoscopic findings, as well as disease severity and extent.
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 adolescent patients.
Dupixent is designed to inhibit 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, including EoE.
Houman Ashrafian, executive vice president, head of research and development at Sanofi, said: “This milestone provides an important new treatment for paediatric patients who were previously without options specifically approved for their disease. With this novel approach to addressing an underlying cause of EoE, Dupixent has the potential to give these young children a better chance to thrive.”
George Yancopoulos, board co-chair, president and chief scientific officer at Regeneron, added: “This approval will bring the proven efficacy and demonstrated safety profile of Dupixent to this vulnerable, young population that has already been established in older EoE patients and has the potential to transform the standard of care for children with EoE…”