FDA OKs Dupilumab Indication for Adolescents with Atopic Dermatitis
With this approval, dupilumab (Dupixent) offers a biologic therapy option for patients 12 to 17 years of age who have moderate-to-severe atopic dermatitis.
Officials with the FDA have approved dupilumab (Dupixent, Regeneron and Sanofi) for patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, according to a press release.
Dupilumab, which is also approved for this indication in adult patients, is the only biologic therapy that targets the interleukin-4 and interleukin-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis. Dupilumab is a subcutaneous injection available in 2 doses, 200 mg and 300 mg, given every other week following an initial loading dose.
The approval is based on data from a phase 3 study evaluating dupilumab monotherapy in adolescents with uncontrolled moderate-to-severe atopic dermatitis.
According to the data, the study showed at 16 weeks:
- The average improvement in the Eczema Area and Severity Index (EASI) from baseline was approximately 66% compared with 24% for placebo.
- More than 10 times as many patients had clear or almost clear skin with dupilumab compared with placebo: 24% of patients who received dupilumab achieved clear or almost clear skin compared with 2% with placebo, as measured by an Investigator’s Global Assessment score of 0 or 1, the primary endpoint of the trial.
- More than 5 times as many patients saw overall disease improvement of at least 75% with dupilumab compared with placebo: 42% of patients who received dupilumab achieved 75% or greater skin improvement compared with 8%, as measured by EASI-75.
- More than 7 times as many patients experienced significantly reduced itch with dupilumab compared with placebo: 37% of patients who received dupilumab achieved a clinically meaningful improvement in itch of at least 4 points on the Peak Pruritus Numerical Rating Scale compared with 5% with placebo.
Overall, the safety and efficacy of dupilumab in adolescent patients were generally consistent with those previously seen in adult studies through 52 weeks. The most commonly reported adverse effects were injection site reactions, eye and eyelid inflammation, pain in throat, and cold sores.
“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,” George D. Yancopoulos, MD, PhD, president and chief scientific officer at Regeneron, said in a statement. “Today’s approval expands the use of Dupixent in the US to include both adults and adolescents with atopic dermatitis or moderate-to-severe asthma.”
Dupilumab is also approved for use with other asthma medications for the maintenance treatment of moderate-to-severe asthma in patients aged 12 years and older whose asthma is not controlled.
Additionally, the FDA recently granted Priority Review status to the supplemental Biologics License Application for dupilumab as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps. If approved, it would be the first FDA-approved biologic therapy for this disease.
FDA Approves Dupixent (Dupilumab) for Moderate-to-Severe Atopic Dermatitis in Adolescents [news release]. Regeneron. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-dupixentr-dupilumab-moderate-severe-atopic. Accessed March 11, 2019.