The FDA approval is based on data from a Phase 3 trial, conducted in two parts, Part A and Part B, evaluating the efficacy and safety of Dupixent 300mg weekly, compared to placebo
Regeneron headquarters under construction. (Credit: Jim.henderson/Wikipedia)
Sanofi and Regeneron have obtained the US Food and Drug Administration (FDA) approval for Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged 12 years and above, weighing at least 40kg.
Dupixent is a human monoclonal antibody designed to inhibit the signalling of interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins, developed by Sanofi in partnership with Regeneron.
The drug has been approved by the US FDA for several indications, including atopic dermatitis, eosinophilic or oral steroid-dependent asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP).
Its current approval in the US follows the FDA Breakthrough Therapy designation for Dupixent in this indication, granted in September 2020, and was evaluated under FDA’s Priority Review.
The FDA approval is based on data from a Phase 3 trial, conducted in two parts, Part A and Part B, evaluating the efficacy and safety of Dupixent 300mg weekly, compared to placebo.
In both parts of the Phase 3 trial, patients treated with Dupixent 300mg experienced a superior reduction in disease symptoms compared to placebo.
The drug showed a 69% reduction in disease symptoms in Part A, and 64% in Part B from baseline, compared to 32% and 41% for placebo.
Sanofi research and development global head John Reed said: “Eating regularly throughout the day is essential, yet significant difficulty swallowing food is a common symptom for people living with eosinophilic esophagitis.
“This can be incredibly upsetting and often leads to fear of pain or choking with every meal, every day. A large unmet need exists for treatment options that can provide meaningful symptom relief.
“Our Phase 3 clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease.”
In a separate development, Regeneron announced positive results for its Evkeeza (evinacumab) to treat homozygous familial hypercholesterolemia (HoFH) in children aged five to 11 years from a Phase 3 study.
Evkeeza is a human monoclonal antibody that inhibits ANGPTL3 to regulate circulating lipids, including LDL-C, developed by Regeneron using its VelocImmune technology.
In the Phase 3 trial, children who received Evkeeza alongside their lipid-lowering therapies experienced a 48% reduction in low-density lipoprotein cholesterol (LDL-C), which is the primary endpoint.
Evkeeza was generally well-tolerated in the trial, with the most common adverse events including throat pain, upper abdominal pain, diarrhoea, headache and nasopharyngitis.