FDA Update: Topical Plaque Psoriasis Treatment Approved; Dupilumab Will Receive FDA Priority Review

The U.S. Food and Drug Administration (FDA) has approved halobetasol propionate lotion as a topical treatment for plaque psoriasis. Also, the agency has accepted for priority review a supplemental biologic license application for dupilumab to treat adolescents with atopic dermatitis.

Halobetasol Propionate Lotion Approved for Plaque Psoriasis
On Nov. 6, the FDA approved halobetasol propionate lotion (Bryhali) to treat adults with plaque psoriasis for up to eight weeks of use. This lotion is a high-potency corticosteroid (0.01%) in a novel vehicle.¹

The approval was based on data from two prospective, multicenter, randomized, double-blind clinical trials. During the studies, 430 patients applied halobetasol propionate lotion once daily for eight weeks. The treatment was well tolerated, with no increase in skin atrophy.

The most common adverse reactions occurring in patients treated through Week 8 were: application site dermatitis (1%), hyperglycemia (1%) and upper respiratory tract infection (2%).

Dupilumab Receives Priority Review
The FDA has accepted the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) for priority review.² Dupilumab is a potential treatment for adolescents 12–17 years old with moderate to severe atopic dermatitis whose disease is not adequately controlled by topical therapies or for whom topical treatment is medically unadvisable. At present, no systemic biologic drugs are FDA approved to treat adolescents with moderate to severe atopic dermatitis.

Dupilumab inhibits interleukin 4 (IL-4) and IL-13 signaling, an important contributor to inflammation. The treatment is currently approved for use in adults and as add-on maintenance therapy for patients 12 years and older with two different types of moderate to severe asthma.

In 2016, the FDA granted breakthrough therapy designation for dupilumab for treating moderate to severe atopic dermatitis in adolescents 12–17 years old, as well as severe atopic dermatitis in children 6 months to 11 years old. The target action date for the FDA decision is March 11, 2019.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Ortho Dermatologics. News release: Ortho Dermatologics announces U.S. launch of Bryhali (halobetasol propionate) lotion, 0.01%, for plaque psoriasis in adults. 2018 Nov 7.
2. Regeneron Pharmaceuticals Inc. News release: FDA grants priority review for Dupixent (dupilumab) as potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis. 2018 Nov 6.