The U.S. Food and Drug Administration Wednesday approved Dupixent, a new, powerful medication for eczema, a skin condition affecting around 15 percent of infants and 3 percent of adults and children in the United States.
Commonly referred to as eczema, atopic dermatitis can cause the skin to develop red, scaly and crusted bumps, which are often itchy.
“Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies,” said Julie Beitz, a director in the FDA’s Center for Drug Evaluation and Research.
Dupixent (dupilumab) is an injection used to treat adult patients with moderate-to-severe eczema (atopic dermatitis). Doctors have prescribed corticosteroid creams and patients bought over-the-counter drugs to lessen inflammation.
Industry analysts anticipate $3 billion in peak annual sales, which is a boon for Sanofi and Regeneron's product lines, according to Biopharmdive.
Three placebo-controlled clinical trials showed participants who received Dupixent had clear or almost clear skin and reported less itching after 16 weeks of treatment, and better results than the placebo group. The study included a total of 2,119 adults with moderate-to-severe eczema.
“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” Beitz said in a statement.