FDA Approves Halobetasol Propionate for Adolescent Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved halobetasol propionate (LEXETTE) foam, 0.05% for the treatment of adolescent patients with plaque psoriasis.

The approval, awarded to Mayne Pharma, is indicated for patients 12 years and old.

The Approval

The topical corticosteroid gained FDA approval in 2018 for adult patients with plaque psoriasis. Both approvals were based on the results of 2 multicenter, randomized, double-blind, vehicle-controlled trials involving 560 patients with plaque psoriasis between 2-12% of total body surface area.

The approval to now include adolescent patients was also based on additional data from an open label study of patients between 12-17 years with plaque psoriasis.

The Disease

Psoriasis affects approximately 8 million patients in the US annually, 1% of which are children and adolescents. Plaque psoriasis is the most common form of psoriasis, accounting for approximately 80% of patients.

“Traditionally, the use of halobetasol has been limited by inconvenient vehicles, which decreased patient compliance, as well as by age and duration restrictions for super potent steroids,” said Neal Bhatia, MD, Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego, one of the investigators in the Phase III study, in a statement. “With the versatility and tolerability of the foam, LEXETTE offers the power of a super potent steroid and the potential to treat adolescents with more affected surface areas.

“Favorable results were demonstrated in the adolescent trial and were comparable to the foam’s previously shown safety, efficacy, and tolerability in adults,” Bhatia added.