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FDA Expands Approval for Dupixent (dupilumab) Use in Adolescents

On Monday, March 11, 2019, the FDA announced that it had expanded approval of the drug Dupixent® (dupilumab) to treat certain adolescents (ages 12-17) with atopic dermatitis. The approval includes children with moderate-to-severe disease, whose condition does not improve with topical prescription medicines or who those who can’t take these other medicines for a variety of reasons.

More about Dupixent (dupilumab)

This is the first so-called “biologic” medicine to be approved for AD in teens. Biologic medicines are scientifically engineered in the laboratory and rely on living cells for production. Dupixent is manufactured by pharmaceutical companies Regeneron and Sanofi.

“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,” said George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron.1,2

What is atopic dermatitis?

Atopic dermatitis, also called atopic eczema, is a chronic, more severe form of eczema—a common skin condition. Both conditions are characterized by scaly patches of dry skin, redness, inflammation, and itching. AD is a relapsing condition. People with the disease experience recurring “flares,” when symptoms become more severe, followed by periods of relief, when symptoms are less intense. AD affects up to 25% of children and 2-3% of adults.

What causes atopic dermatitis?

The exact cause of atopic dermatitis is not fully understood, but researchers believe it stems from a combination of genetic and environmental factors. Experts think it results from an overly active immune system responding to normally benign triggers or irritants by creating an overproduction of immune factors and inflammation. These are responsible for the redness, swelling, and itching that are common symptoms in people with AD.

The fact that researchers understand more about the underlying molecular causes of AD in the body has helped them develop targeted drugs to improve the condition.

How effective is dupilumab?

The approval of this medication was based on results from a Phase III clinical research study. This type of study looked at the safety and efficacy of the medicine in adolescents. The results were clear-cut. For example, the teens who took the medicine experienced a 66% reduction of symptoms, whereas those on the placebo improved only 24%.

The researchers also found that 24% of people on the medication achieved clear or almost clear skin, compared to 2% taking the placebo. Additionally, over five times the number of people on dupilumab had at least 75% improvement in disease severity.2

How does dupilumab work?

Dupilumab is an injectable monoclonal antibody that disrupts certain immune system factors called interleukin-4 and interleukin-13. Antibodies are substances in the body that help the immune system fight disease. This medication was specially formulated to bind to human interleukin-4 and -13 and block their action of stimulating inflammation.

Blocking these immune system elements helps tamp down the inflammation, redness, and itching that underlie many atopic dermatitis symptoms.

How do you take dupilumab?

For adolescents, the dose of dupilumab depends on body weight. It is an injected medication, given every two weeks. People can take dupilumap either on its own or with topical ointment-type medicines containing steroids.3-6

  1. Joe Barber. Sanofi, Regeneron's Dupixent gains expanded approval in US for certain adolescents with atopic dermatitis. March 11, 2019. FirstWord Pharma. Available at http://www.firstwordpharma.com/node/1628957#axzz5hxi2SSso Accessed Wednesday, March 13, 2019.
  2. Ashley Lyles. FDA OKs Dupixent for Atopic Dermatitis in Teens. March 11, 2019. MedPage Today. Available at https://www.medpagetoday.com/dermatology/generaldermatology/78501 Accessed March 13, 2019.
  3. What is the Difference between Eczema and Atopic Dermatitis? National Eczema Association. https://nationaleczema.org/eczema/ Accessed March 15, 2018.
  4. Robert Sidbury, Dawn M. Davis, David E. Cohen, et. al., Guidelines of Care for the Management of Atopic Dermatitis. Journal of the American Academy of Dermatology. August 2014; 71(2): 327–349. Available from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410179/#S12title. Accessed March 15, 2018.
  5. Atopic Dermatitis-Eczema. The Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/atopic-dermatitis-eczema/symptoms-causes/syc-20353273. Published March 6, 2018. Accessed March 15, 2018.
  6. Prescribing Information. 2019 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC. Issue Date: March 2019. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761055s012lbl.pdf Accessed March 13, 2019.

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