Sanofi and Regeneron’s Dupixent (dupilumab) has been recommended for use in the EU to treat severe atopic dermatitis in children aged six months to five years who are candidates for systemic therapy.
Following this positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, a final decision on the companies’ application is expected to be announced in the coming months by the European Commission.
If approved, Dupixent would be the first and only targeted medicine in the EU for this patient population.
Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before the age of five, often continuing throughout adulthood.
Symptoms include intense, persistent itch and skin lesions covering much of the body and resulting in skin dryness and pain, which can increase the risk of skin infection.
Currently, treatment options in this age group are primarily topical corticosteroids (TCS), which the companies say can be associated with safety risks and may impair growth when used long term.
Dupixent is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 and interleukin-13 pathways, shown in the Dupixent development programme to be central of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
The companies’ EU application was supported by data from a phase 3 trial in children aged six months to five years in which Dupixent was shown to improve skin clearance, reduce overall disease severity and improve health-related quality of life.
The medicine was approved by the US Food and Drug Administration in June 2022 for patients in this age group with moderate-to-severe atopic dermatitis.
“Young children with moderate-to-severe atopic dermatitis are a significantly underserved population of patients, who spend vulnerable years of their lives suffering through the relentless and far-reaching effects of this chronic disease,” George Yancopoulos, Regeneron’s president and chief scientific officer, said at the time of the announcement.
In addition to its indications in atopic dermatitis, Dupixent has also received regulatory approvals in one or more countries worldwide for use in certain patients with prurigo nodularis, asthma, chronic rhinosinusitis with nasal polyposis, or eosinophilic esophagitis in different age populations.
The companies are also currently studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes.