FDA approved on Tuesday dupilumab (Dupixent—Regeneron Pharmaceuticals) injection for the treatment of adults with moderate-to-severe eczema. The drug is intended for individuals whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupilumab can be used with or without topical corticosteroids. "FDA's approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease," said Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA's Center for Drug Evaluation and Research. "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." Dupilumab's safety and efficacy were demonstrated in three placebo-controlled clinical trials that included more than 2,100 adults with moderate-to-severe atopic dermatitis not adequately controlled by topical medication. Study participants who received dupilumab saw a greater response, defined as clear or nearly clear skin, and saw a reduction in itch after 4 months of treatment. The drug can cause serious adverse effects including serious allergic reactions and eye problems such as conjunctivitis and keratitis. The most common adverse effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling, and itching.