FDA Expands Approval of Two Plaque Psoriasis Therapies to Include Younger Patients

The Food and Drug Administration (FDA) has expanded the approval for two plaque psoriasis therapies to include younger patients.

Enstilar Foam (calcipotriene and betamethasone dipropionate; LEO Pharma) is now indicated for the topical treatment of plaque psoriasis in patients 12 years and older. Previously, the topical treatment had only been approved for patients aged ≥18 years. The approval was based on data from the Enstilar Pediatric Study (N=117) which established the safety and efficacy of Enstilar Foam in patients 12 to 17 years of age.

Each gram of Enstilar Foam contains 50mcg of calcipotriene, a vitamin D analogue, and 0.643mg of betamethasone dipropionate, a corticosteroid. The product is supplied in 60g cans.

In addition, Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate; LEO Pharma) has been approved for the topical treatment of plaque psoriasis of the scalp and body in patients 12 years and older. Previously, the treatment had only been indicated for plaque psoriasis of the body in patients aged ≥18 years. The use of Taclonex Topical Suspension for this indication is supported by evidence from uncontrolled trials in pediatric patients that enrolled 107 adolescents with psoriasis of the scalp and body.

Each gram of Taclonex Topical Suspension contains 50mcg of calcipotriene and 0.643mg of betamethasone dipropionate. The product is supplied in 60g bottles.

“Healthcare professionals now have a once-daily topical treatment option with Enstilar for their adolescent patients age 12 and older who are affected by plaque psoriasis,” said Joyce Teng, MD, PhD, Professor of Dermatology and Pediatrics at Stanford University, and study investigator. “Managing adolescents with body and scalp plaque psoriasis can be very challenging for dermatologists. We welcome this FDA approval for these children with unmet medical needs.”

For more information visit leo-pharma.us.