Mayne Pharma Group Ltd. said the U.S. Food and Drug Administration approved its Sorilux foam for treating plaque psoriasis in adolescents.
The therapy is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and above. Sorilux was previously approved by the U.S. regulator for treating plaque psoriasis in patients aged 18 years and older.
The additional approval is based on further data obtained in a follow-on open-label study in psoriasis patients aged 12 to 17 years.
Psoriasis is an autoimmune disease — a condition where the immune system attacks healthy cells by mistake — of the skin which affects 7.5 million Americans annually. Plaque psoriasis affects about 80% of people with the disorder.
Australian drugmaker Mayne Pharma acquired Sorilux from GlaxoSmithKline PLC in 2016.