The FDA approval is based on data from a Phase 3 trial which evaluated the efficacy and safety of Dupixent in combination with low-potency topical corticosteroids (TCS), compared to TCS alone (Placebo)
Dupixent is jointly developed by Sanofi and Regeneron. (Credit: Myriams-Fotos from Pixabay)
The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat a type of atopic dermatitis (eczema) in children aged six months to five years.
The drug was indicated for eczema in the young children, for whom topical prescription therapies are not adequate, or who are not eligible for those therapies.
Dupixent is an anti-interleukin-4 (IL-4) and anti-interleukin-13 (IL-13) antibody therapy, developed by Sanofi in partnership with Regeneron.
The drug was previously approved in the US and Europe, for several indications, including severe asthma, atopic dermatitis, and eosinophilic esophagitis, among others.
Atopic dermatitis is a chronic type 2 inflammatory skin disease, characterised by persistent itch and skin lesions that result in skin dryness, cracking, pain, redness or darkening, and crusting and oozing, along with an elevated risk of skin infections.
Sanofi senior vice president and immunology and inflammation global development head Naimish Patel said: “Until today, treatment options in the US for infants and children under the age of six suffering from moderate-to-severe atopic dermatitis have been limited to topical steroids – which may be associated with significant safety risks when used long-term.
“This has left patients and their caregivers in desperate need of medicines that can better address the chronic, long-term nature of the disease. These young people, and their families, often struggle to cope with the significant impact itch can have on them.
“This approval means that Dupixent, with its well-established safety and efficacy profile, is now available to some of the youngest people living with this disease.”
The FDA approval is based on data from a Phase 3 trial which evaluated the efficacy and safety of Dupixent in combination with low-potency topical corticosteroids (TCS).
The Phase 3 trial compared Dupixent plus TCS to low-potency TCS alone (placebo) in 162 children aged six months to five years with uncontrolled moderate-to-severe atopic dermatitis.
The primary endpoints include a proportion of patients achieving an Investigator’s Global Assessment (IGA) score of 0-1 and 75% improvement in the Eczema Area and Severity Index.
Additional outcome measures include itch reduction, assessed using a caregiver-reported 0 to 10 Numerical Rating Scale, with a clinically meaningful improvement.
The study met the primary and all secondary endpoints and showed that Dupixent has a safety profile similar to that observed in atopic dermatitis patients aged six years and above.
Dupixent is being jointly developed by Sanofi and Regeneron under a global collaboration and is being studied in a wide range of diseases driven by type 2 inflammation.