Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the European Commission to treat severe atopic dermatitis in children aged six months to five years who are candidates for systemic therapy.
The approval, which follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use earlier this year, makes Dupixent the first and only targeted medicine in the EU for this patient population.
Around 80,000 infants and young children in Europe are living with uncontrolled cases of atopic dermatitis, a chronic type 2 inflammatory skin disease.
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, 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 to type 2 inflammation.
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.
Naimish Patel, head of global development, immunology and inflammation at Sanofi, said: “With this latest approval, Dupixent is the first-ever biologic medicine for people living with atopic dermatitis from infancy to adulthood.
“Given its well-established safety and efficacy profile, Dupixent has the potential to transform the landscape for people of all ages living with atopic dermatitis.”
Dupixent has already received regulatory approvals for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis.
As well as the currently approved indications, the partners are studying the medicine across a broad range of diseases driven by type 2 inflammation or other allergic processes, including certain patients with urticaria, chronic pruritus and chronic obstructive pulmonary disease.
“Dupixent is currently being used to treat more than 600,000 patients around the word across approved indications,” said George Yancopoulos, president and chief scientific officer at Regeneron. “This latest EU approval brings the proven efficacy, and importantly, the long-term safety profile of Dupixent to this particularly vulnerable population.”