FDA Approves Dupixent to Treat Eczema in Young Children

The US Food and Drug Administration (FDA) approved the use of the anti-inflammatory drug Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, to treat eczema in young children, the companies said.

“Until today, treatment options 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 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,” said Naimish Patel, Senior Vice President, Head of Global Development, Immunology and Inflammation, Sanofi.

Dupixent became the first and only medicine approved to treat moderate-to-severe eczema from infancy to adulthood, informed Sanofi. Atopic dermatitis (or eczema) is a non-contagious inflammatory skin condition. It is a chronic disease characterized by dry, itchy skin that can weep clear fluid when scratched. People with eczema also may be particularly susceptible to bacterial, viral and fungal skin infections, according to the National Institute of Allergy and Infectious Diseases.

Between 85-90 percent of eczema patients first develop symptoms before five years of age, which often continue through adulthood, according to Sanofi. In the US, over 75,000 children aged five years and younger present uncontrolled moderate-to-severe cases. Despite the limited epidemiological information of atopic dermatitis in Mexico, a study found out that the prevalence of the disease over the past 30 years is around 20 percent. From the total eczema cases, 60 percent appear during the first year of life and in 70 percent of the patients it remits before the age of 16 years old.

The FDA approval of Dupixent for its use in children aged six months to five years was based on data from a late-stage study in which the drug improved skin clearance and reduced severity of eczema when used with a corticosteroids cream, reported Reuters. Dupixent is administered as a subcutaneous injection at different injection sites. In young children, it is administered with a pre-filled syringe every four weeks. The drug works by blocking the IL-4 and IL-13 proteins, which cause the inflammation and are involved in the body’s immune response.

Dupixent is Sanofi’s best-selling product by far. In 2021, its sales amounted to US$5.64 billion, 13.9 percent of the group’s revenue. In March 2022, the company said that it expected sales of over US$13.77 billion for Dupixent during 2022, up from a previous target of US$10.74 billion.