FDA Approves Dupixent for Moderate to Severe AD in Adolescents

Monday, March 11, 2019 | FDA Approval/Clearance , Atopic Dermatitis , Regeneron , Sanofi


The FDA has approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SA's eczema drug Dupixent to include patients aged 12 through 17 whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Dupixent can be used with or without topical corticosteroids.

"For the first time, adolescents with uncontrolled moderate-to-severe atopic dermatitis have an approved biologic treatment option to help control persistent, often debilitating symptoms such as chronic itch and widespread rash. Today's approval expands the use of Dupixent in the U.S. to include both adults and adolescents with atopic dermatitis or moderate to severe asthma," says George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer at Regeneron, in a news release. "Given that Dupixent targets a key pathway in type 2 inflammation, we are also investigating it in a broad development program in patients with other type 2 inflammatory diseases including eosinophilic esophagitis, chronic rhinosinusitis with nasal polyps, where we recently announced positive Phase 3 results and Priority Review of a U.S. regulatory submission, and food and environmental allergies."

The FDA evaluated the Dupixent application under Priority Review. Dupixent was also granted Breakthrough Therapy designation by the FDA for inadequately controlled moderate-to-severe atopic dermatitis in adolescents. The Breakthrough Therapy designation was created to expedite the development and review of drugs developed for serious or life-threatening conditions.  

In the pivotal Phase 3 trial evaluating Dupixent monotherapy in adolescent patients with uncontrolled moderate-to-severe atopic dermatitis, the safety and efficacy were generally consistent with that previously seen in adult studies. At 16 weeks:

  • The average improvement in the Eczema Area and Severity Index (EASI) from baseline was approximately 66 percent compared to 24 percent for placebo
  • More than 10 times as many patients had clear or almost clear skin with Dupixent compared to placebo: 24 percent of patients who received Dupixent achieved clear or almost clear skin compared to 2 percent with placebo, as measured by an Investigator's Global Assessment (IGA) score of 0 or 1, the primary endpoint of the trial
  • Over five times as many patients saw overall disease improvement of at least 75 percent with Dupixent compared to placebo: 42 percent of patients who received Dupixent achieved 75 percent or greater skin improvement compared to 8% with placebo, as measured by EASI-75
  • Over seven times as many patients experienced significantly reduced itch with Dupixent compared to placebo: 37 percent of patients who received Dupixent achieved a clinically meaningful improvement in itch of at least four points on the Peak Pruritus Numerical Rating Scale (NRS) compared to 5% with placebo

The safety profile of Dupixent in the adolescent trial was similar to the safety profile from trials in adults with atopic dermatitis, and consistent through 52 weeks. The most common adverse events were injection site reactions, eye and eyelid inflammation including redness, swelling and itching, oropharyngeal pain and cold sores in the mouth or on the lips.

"This is a really big deal because there are so many adolescents and children with eczema," says Emma Guttman-Yassky MD, PhD, Vice Chair for Research in the Department of Dermatology and Director of the Center for Excellence in Eczema at Mount Sinai Hospital in New York City. "For many of these patients, topicals aren't enough and phototherapy isn't feasible."

"Dupixent is a very safe treatment, and we hope in the future, its use will be expanded to include early childhood." Dr. Guttman-Yassky's research and clinical trials helped lead to FDA approval in adults and children and adolescents.

 

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