Dupixent Injection Approved for Atopic Dermatitis

Dupixent Injection (dupilumab; Regeneron Pharmaceuticals Inc. and Sanofi) received approval from the FDA late last month for the treatment of adults with moderate to severe atopic dermatitis not adequately controlled with topical prescription therapies or for whom such therapies are inappropriate.

Dupixent is the only biologic medicine approved for use in this population. Its safety in children and adolescents is currently being evaluated.

A human monoclonal antibody, Dupixent is geared to inhibit overactive signaling of IL-4 and IL-13 proteins, which are thought to be major drivers of underlying inflammation in atopic dermatitis. Packaged in a prefilled syringe, Dupixent is self-administered as a subcutaneous injection every other week after an initial loading dose. The biologic can be used with or without topical corticosteroids.

Approval was based on data from three randomized phase 3 trials. Two of the studies examined Dupixent use alone, and one looked at its use along with topical corticosteroids.

The studies investigating Dupixent as a monotherapy involved a total 1379 adults. They found that Dupixent alone significantly improved measures of skin clearing and overall extent and severity of atopic dermatitis at 16 weeks.

Some 740 adults were included in the trial of Dupixent used with topical corticosteroids. It found, when compared with placebo with topical corticosteroids, Dupixent with topical corticosteroids significantly improved measures of overall disease severity at 16 and 52 weeks.

The most common adverse events included injection site reactions, eye and eyelid inflammation, and cold sores in the mouth or on the lips.   

The wholesale acquisition cost of Dupixent is $37,000 annually. Actual costs to payers, patients, and health systems are expected to be lower, according to Regeneron, since wholesale acquisition pricing does not reflect discounts, rebates, or patient assistance programs.

 “People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives,” said Julie Block, president and chief executive officer of the National Eczema Association. “To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease. That’s why today’s approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease.”—Jolynn Tumolo