FDA Approves Dupilumab for Treatment of Eczema

The FDA granted approval to dupilumab (Dupixent) injection for the treatment of adults with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or for whom these therapies are not advisable.

Dupilumab is a human monoclonal antibody, designed to specifically inhibit overactive signaling of the proteins IL-4 and IL-13, according to a press release. These key proteins are believed to be major drivers of the underlying inflammation in AD.

“People with moderate to severe [AD] cope with intense, sometimes unbearable, symptoms that can impact them for most of their lives,” Julie Block, president and CEO of the National Eczema Association, said in a release. “To date, there have been few options available to treat people with moderate to severe [AD] 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.”

The approval is based on data from the global LIBERTY AD clinical program, which is comprised of 3 randomized phase 3 pivotal trials SOLO 1, SOLO 2, and CHRONOS. The studies examined the use of dupilumab either alone or in combination with topical corticosteroids in patients with moderate to severe AD.

In all 3 studies, dupilumab alone or in combination with topical corticosteroids met the primary and key secondary endpoints, according to the release.

Patients treated with dupilumab monotherapy in the SOLO 1 and SOLO 2 studies, experienced significant improvement in measures of skin clearing and overall extent and severity of disease.

At 16 weeks, 38% of patients in the SOLO 1 trial and 36% in the SOLO 2 trial who received 300 mg of dupilumab every 2 weeks achieved clear or almost clear skin—–measured by the 5-point Investigator’s Global Assessment scale––compared with 10% and 9% with placebo, respectively.

In the same trials at 16 weeks, 51% and 44% of patients, respectively, who received 300 mg of dupilumab every 2 weeks achieved a 75% or greater reduction in the Eczema Area and Severity Index Score (EASI-75) from baseline (key secondary endpoint) compared with 15% and 12% with placebo.

Furthermore, 41% and 36% of patients who received 300 mg of dupilumab every 2 weeks achieved a greater than or equal to 4-point improvement in the daily intensity of patient-reported itch—–measured by the Pruritus Numerical Rating Scale (NRS)––compared with 12% and 10% with placebo.

In the CHRONOS study, patients treated with dupilumab plus topical corticosteroids (TCS) significantly improved measures of overall disease severity at 16 and 52 weeks, when compared with placebo plus TCS.

At 16 weeks, 39% of patients who received 300 mg of dupilumab every 2 weeks with TCS achieved clear or almost clear skin compared with 12% of patients receiving placebo plus TCS. Sixty-nine percent of patients achieved EASI-75 compared with 23% of patients who received placebo plus TCS.

Furthermore, 59% of patients who received 300 mg of dupilumab every 2 weeks with TCS achieved a greater than or equal to 4-point improvement in the daily intensity of patient-reported itch, compared with 20% of patients who received placebo plus TCS.

The CHRONOS study also met additional key secondary endpoints at 52 weeks, demonstrating that 36% of patients who received 300 mg of dupilumab every 2 weeks with TCS achieved clear or almost clear skin, compared with 13% of patients receiving placebo with TCS.

The most common adverse events greater than or equal to 1% with dupilumab were injection site reactions, eye and eyelid inflammation—including redness, swelling, and itching—and cold sores in the mouth or on the lips.

“Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases,” George D. Yancopoulos, MD, PhD, founding scientist, president, chief scientific officer of Regeneron, said in the release. “In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease. Today’s approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program.”

Dupilumab comes in a prefilled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. It will be available later this week in the United States, with a wholesale acquisition cost (WAC) of $37,000 per year. The actual cost of dupilumab to patients, payers, and health systems are expected to be lower because WAC pricing does not reflect rebates, discounts, or patient assistance programs.

“We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people's lives,” Olivier Brandicourt, MD, CEO of Sanofi, said in the release. “The approval of Dupixent offers new hope for adults with moderate to severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally.”