Dupixent (dupilumab), developed by Sanofi and Regeneron, has recently achieved significant regulatory milestones across multiple regions and indications, reinforcing its role in treating type-2 inflammatory diseases.
EU Approval for Eosinophilic Esophagitis (EoE) in Young Children
The European Commission granted approval for Dupixent in young children with eosinophilic esophagitis (EoE), expanding its initial EU approval for adults and adolescents. This makes Dupixent the first and only medicine indicated to treat these young patients in the EU. The approval mirrors similar decisions in the US and Canada.
The approval was based on the two-part EoE KIDS phase 3 study in children aged 1 to 11 years. Part A of the study demonstrated that children receiving a higher, weight-based dose of Dupixent (n=37) experienced significant improvements compared to placebo (n=34) at 16 weeks:
- 68% achieved histological disease remission (≤6 eosinophils/high power field) compared to 3% in the placebo group, meeting the primary endpoint. These results were sustained for up to one year in Part B of the study.
- An 86% reduction in peak esophageal intraepithelial eosinophil count from baseline, compared to a 21% increase in the placebo group.
The safety results in the EoE KIDS study were consistent with the known safety profile of Dupixent in older patients with EoE.
CHMP Recommendation for EoE in Adults and Adolescents
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Dupixent for adults and adolescents (12 years and older, weighing at least 40 kg) with eosinophilic esophagitis (EoE) who are inadequately controlled by, intolerant to, or not candidates for conventional medicinal therapy. If approved by the European Commission, Dupixent would be the first and only targeted medicine specifically indicated for this population in the EU.
The CHMP's positive opinion was based on pivotal trial data demonstrating that patients on Dupixent 300 mg weekly experienced significantly improved ability to swallow and achieved histological disease remission compared to placebo.
US and China Approve Dupixent for COPD
Dupixent received approval from both the US Food and Drug Administration (FDA) and China's National Medical Products Administration (NMPA) as an add-on maintenance treatment for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. This marks the first biologic medicine approved for COPD in both countries.
The approvals were based on data from the BOREAS and NOTUS trials. The BOREAS trial showed a 30% reduction in COPD exacerbations, while the NOTUS trial demonstrated a 34% reduction. Nearly 1,000 patients were treated across the two trials.
"This latest FDA approval for Dupixent represents new hope for the hundreds of thousands of COPD patients in the US who can sometimes struggle just to breathe during their everyday lives," said Dr. George D. Yancopoulos, president and chief scientific officer at Regeneron.
Dr. Houman Ashrafian, EVP and head of research and development at Sanofi, noted, "China has the largest number of people living with COPD worldwide, and a significant proportion of patients are uncontrolled on current therapies and desperate for an effective treatment option."
Dupixent functions by inhibiting the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is administered via subcutaneous injection, with dosing regimens varying based on the specific condition and patient weight.
