Priority Review for Dupixent in Adolescents

Dupixent® (dupilumab) is a medication that is currently being reviewed by the U.S. Food and Drug Administration (FDA) for use in adolescents (aged 12 to 17) with moderate-to-severe atopic dermatitis (AD) and just received priority review status.¹ Priority review is a designation that the FDA gives to certain treatments that mean they will take action on their review within 6 months, rather than the usual 10 months in a standard review process.² The target action date (when approval may be granted by the FDA) is March 11, 2019.

Adolescent atopic dermatitis

Dupixent has already been approved for use in adults with moderate-to-severe AD whose disease has not been adequately controlled with topical prescription treatments, and it is also approved to treat patients aged 12 and older with moderate-to-severe asthma. Dupixent has been in clinical trials to assess its effectiveness and safety for use in adolescents with AD. There are currently no biologic treatments available for adolescents with moderate-to-severe AD, and if approved, Dupixent could offer teens with AD a new treatment option.³

Promising data from research studies on adolescents

The priority review status was at least partially based on promising data from clinical trials of the use of Dupixent in adolescents with moderate-to-severe AD. The data was presented at the European Academy of Dermatology and Venereology in September 2018. Results from the clinical trials demonstrated that 41.5% of patients who received Dupixent every two weeks, as well as 38% who received it every four weeks, achieved at least 75% improvement in their skin symptoms, compared to just 8% of those on placebo achieving a similar improvement.¹

Dupixent side effects

Like all medications, Dupixent can cause side effects, including changes in vision or severe allergic reactions (hypersensitivity), which may require immediate medical attention. The most common side effects experienced by people taking Dupixent include injection site reactions, eye and eyelid inflammation (including redness, swelling, and itching), and cold sores on the mouth or lips. In some people with asthma, a rare but serious side effect of inflammation of the blood vessels can occur with Dupixent.⁵

How Dupixent works

Dupixent is an injectable medication given under the skin (subcutaneously). The active ingredient in Dupixent, dupilumab, is a monoclonal antibody that is made to attach to a particular substance. Dupixent targets interleukin-4 (IL-4) and interleukin-13 (IL-13), two chemicals that are involved in the inflammatory response of the immune system. In people with AD, there is a dysfunction in the immune system, which results in an overactive, inflammatory state. By suppressing the inflammatory response, Dupixent may improve the symptoms of AD, including itching, redness, and rash.^4,5