Dupixent clears PhIII trial in new disease as blockbuster looks to expand past Regeneron-Sanofi split
Sanofi and Regeneron may be splitting up, but their billion-dollar baby, Dupixent, keeps on growing.
Already grossing over $2 billion last year based on FDA approvals for asthma and atopic dermatitis and a form of rhinosinusitis, Dupixent may be nearing a fourth indication: Eosinophilic esophagitis (EoE), an inflammatory disease marked by the buildup of white blood cells in the esophagus and which affects around 160,000 US patients annually.
On Friday, the companies announced the first part of their Phase III EoE trial met both primary endpoints and all secondary endpoints. Across 81 patients, those on the Dupixent arm saw a 69% drop in disease severity, as measured by a patient survey called the Dysphagia Symptom Questionnaire, compared to a 32% drop in the placebo arm. The Dupixent patients also saw a 60% reduction in eosinophils – the white blood cells whose buildup drives the disease – in their esophagus, compared to 5% in the control group.
Adverse event reports were 86% in the drug arm and 82% in the placebo.
“These data demonstrate Dupixent’s potential to continue to address treatment gaps across the spectrum of type 2 inflammatory diseases as common as asthma and as rare as eosinophilic esophagitis,” Sanofi R&D chief John Reed said in a statement.
Dupixent had been developed as part of a partnership between Sanofi and Regeneron that began in 2013, and was seen as the key success of that deal when the pair began decoupling last year and, this week, when Sanofi signaled it would sell off the vast majority of its 23.2 million Regeneron shares.
Although asthma and eczema are likely to remain Dupixent’s bread-and-butter markets, the $5 to $10 billion peak sales estimates that some analysts have pegged for the drug are dependent in part on approving new indications, particularly as JAK inhibitors look to nab more of the market. The drug was approved for children between the ages of 6 and 11 with atopic dermatitis this week. Trials are also underway for prurigo nodularis, chronic spontaneous urticaria and bullous phemphigold.
Dupixent, an IL-13/IL-4 inhibitor, would have few rivals for EoE, a condition that is generally treated with diet, steroids and acid suppressors. The trial still has two more parts to it, including different dosing and extended treatment.