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Published On: Mar 12, 2019
Last Updated On: Jul 13, 2021
On March 11, 2019, the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab), the first biologic medication for adolescents aged 12 to 17 with moderate to severe atopic dermatitis (AD) for whom other treatments have not worked.
Dupixent first received FDA approval in March 2017 for adult patients whose moderate to severe AD was not well-controlled by topical prescription therapies. In October 2018, it was approved for the maintenance treatment of moderate to severe asthma in people aged 12 years and older whose asthma is not controlled with their current asthma medicines.
Different from topical or oral medications, Dupixent is a biologic drug or “biologic” made from proteins derived from living cells or tissues. If you’ve received a vaccine or had a blood transfusion, you’ve had a first-generation biologic.
Dupixent falls in the next-generation category of biologics. Made with modified, or “recombinant” human DNA, these drugs are genetically engineered to control specific immune system reactions that lead to inflammatory diseases such as atopic dermatitis.
Because biologics are made from proteins, they must be given by injection or infusion. Dupixent comes in two doses (200 mg and 300 mg), each as a pre-filled syringe. It is intended for injection under the skin (subcutaneous injection) and is administered every other week following an initial loading dose.
Dupixent works by blocking the proteins called interleukins, or ILs, from binding to their cell receptors. Interleukins contribute to a functioning immune system by helping to fight off viruses or bacteria in our bodies.
When the immune system goes haywire, it can trigger certain ILs to mistakenly attack the body, resulting in chronic inflammatory conditions such as atopic dermatitis. Dupixent is the only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies AD.
Dupixent has been studied in more than 7,000 patients 12 years and older in more than 30 clinical trials. After its Phase 3 clinical trial, drug makers Sanofi and Regeneron reported that Dupixent significantly reduced the extent and severity of disease and itching, and helped adolescents achieve clearer skin.
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, pain in the throat (oropharyngeal pain) and cold sores in the mouth or on the lips.
For more information, talk to your medical provider or visit www.dupixent.com.