The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole EoE medicine authorized in the US for this age group, extending the pediatric setting from the previously approved range of 12 years and above.
The FDA’s decision was bolstered by positive results from a late-stage trial, which achieved a primary endpoint of a 66% histological disease remission rate compared to a 3% rate for placebo after 16 weeks. This benefit was maintained at week 52, with 53% of Dupixent users experiencing sustained effects. The safety profile for the new age range was found to be consistent with that observed in patients aged above 12 years.
Dupixent, a biologic drug, is also approved in the US for other chronic diseases driven by type 2 inflammation, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), and prurigo nodularis.- Flcube.com
