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Dupixent Wins FDA Approval to Treat Moderate-to-Severe Atopic Dermatitis
Dupilumab injection (Dupixent, Regeneron/Sanofi) has received FDA approval as the first biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Dupilumab is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, interleukin (IL)-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupilumab comes in a prefilled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. It can be used with or without topical corticosteroids.
AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing. Itch is one of the most burdensome symptoms for patients and can be debilitating. Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.
The wholesale acquisition cost (WAC) of dupilumab in the United States is $37,000 annually. Actual costs to patients, payers, and health systems are anticipated to be lower because WAC pricing does not reflect discounts, rebates, or patient assistance programs.
Dupilumab received FDA priority review and a breakthrough therapy designation. Its approval was based on data from the global LIBERTY AD clinical program, which included three randomized phase 3 pivotal trials known as SOLO 1, SOLO 2, and CHRONOS that enrolled 2,119 adults. The studies examined the use of dupilumab either alone (SOLO 1 or SOLO 2) or with topical corticosteroids (CHRONOS) in patients with inadequately controlled moderate-to-severe AD.
In the SOLO 1 and SOLO 2 studies, treatment with dupilumab as monotherapy significantly improved measures of skin clearing and overall extent and severity of disease. At 16 weeks among patients who received dupilumab 300 mg every two weeks in SOLO 1 and SOLO 2, respectively, 38% and 36% achieved clear or almost clear skin as measured by the 5-point Investigator's Global Assessment (IGA) scale, compared to 10% and 9% with placebo. In addition, 51% and 44% of patients who received dupilumab achieved a 75% or greater reduction in their Eczema Area and Severity Index score (EASI-75) from baseline, compared to 15 and 12% with placebo.
In the CHRONOS study, treatment with dupilumab and topical corticosteroids (TCS) significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS. At 16 weeks, 39% of patients who received dupilumab 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 12% of patients receiving placebo with TCS. In addition, 69% of patients who received dupilumab with TCS achieved EASI-75, compared to 23% of patients receiving placebo with TCS.
The most common adverse events that were noted to be greater than or equal to 1% with dupilumab treatment included injection site reactions, eye and eyelid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.
Source: Regeneron Pharmaceuticals, Inc.; March 28, 2017.