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Officials with the FDA have taken action on LEO Pharmaâ€™s calcipotriene and betamethasone dipropionate foam and topical suspension products for the topical treatment of plaque psoriasis in patients age 12 years and older.
Officials with the FDA have expanded the indication for LEO Pharma’s calcipotriene and betamethasone dipropionate (Enstilar) foam, 0.005%/0.064%, for the topical treatment of plaque psoriasis to include patients age 12 years and older.
The product was previously indicated only for patients age 18 years and older.
In approving the expanded indication, the FDA has extended the period of United States market exclusivity by an additional 6 months to Dec. 10, 2031, according to the company. The action is supported by the Enstilar Pediatric Study (NCT02387853) in adolescents age 12 to 17 years with psoriasis of the body and scalp, and data from trials in adults.
According to LEO, the new indication provides adolescent patients with plaque psoriasis a once-daily topical treatment option for that they did not previously have available to them. Calcipotriene and betamethasone dipropionate foam is intended for application to affected areas once daily for up to 4 weeks, and patients should not apply more than 60 grams every 4 days. Treatment should be discontinued when control is achieved.
Adverse reactions reported in <1% of subjects treated with calcipotriene and betamethasone dipropionate foam in clinical trials included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis, according to LEO.
In announcing the expanded indication for the foam product, LEO also announced the FDA’s approval of calcipotriene and betamethasone dipropionate topical suspension (Taclonex) for the topical treatment of scalp and body psoriasis in patients age 12 years and older.
The safety and effectiveness of each of these 2 products has not been established in pediatric patients under age 12 years.