The US Food and Drug Administration approved the use of Sanofi and Regeneron Pharmaceuticals Inc's anti-inflammation drug Dupixent to treat eczema in young children, the two companies said on Tuesday.
Dupixent is now the first approved treatment for moderate-to-severe eczema in young children, Sanofi and Regeneron said.
Sanofi records global net product sales of Dupixent, while Regeneron gets a share of profit or loss from the drug.
The approval for the drug in children aged 6 months to 5 years was based on data from a late-stage study in which Dupixent improved skin clearance and reduced severity of eczema when used with a corticosteroids cream.
The drug works by blocking the inflammation-causing IL-4 and IL-13 proteins involved in the body's immune response that the companies believe to be underlying reasons for a number of inflammatory conditions.
Dupixent, with 2021 sales of 5.25 billion euros, accounted for 13.9% of Sanofi's revenue, making it the Paris-listed company's best-selling product.
Dupixent is already approved for treating a range of diseases in adult populations in the United States, including eczema or atopic dermatitis, severe asthma and an allergic inflammation of the esophagus.
Atopic dermatitis, or eczema, is a chronic skin condition that causes inflammation and irritation of skin. It affects about 30% of the US population, mostly children and adolescents, according to the National Institute of Allergy and Infectious Diseases.