FDA Extends Mayne Pharma’s Plaque Psoriasis Treatment to Adolescents
Global pharmaceutical company Mayne Pharma, which has major U.S. facilities in Raleigh and Greenville, has earned approval from the U.S. Food and Drug Administration for its topical corticosteroid LEXETTE to treat moderate to severe plaque psoriasis in patients 12 and older.
LEXETTE was originally approved by the FDA in 2018 to treat plaque psoriasis in adults. Now the U.S. subsidiary of Australia’s Mayne Pharma Group Limited can sell the drug to adolescents, thanks to a successful follow-on, open-label study. During this study, the company was able to show results in adolescents comparable to the safety, efficacy and tolerability in adults.
In a news release, CEO Scott Richards said, “LEXETTE has been shown to be a safe and effective treatment option, and with this approval, we're pleased to offer LEXETTE to young people living with this challenging indication."
San Diego dermatologist Neal Bhatia, one of the company’s investigators in the Phase 3 study, said Mayne’s plaque psoriasis treatment “…offers the power of a super-potent steroid and the potential to treat adolescents with more affected surface areas.”
According to research provided by the National Psoriasis Foundation and the American Academy of Dermatology, some eight million Americans are impacted by psoriasis each year, roughly 80% of whom have plaque psoriasis.
Mayne Pharma sells more than 20 dermatology products in the U.S., which includes a women's health portfolio.