The US Food and Drug Administration (FDA) has approved Australia-based Mayne Pharma Group Limited's (ASX: MYX) SORILUX (calcipotriene) Foam, 0.005% to treat adolescents, it was reported yesterday.

The product is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older. SORILUX Foam contains calcipotriene, a synthetic vitamin D analogue that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

The FDA first approved the product for treating adults with plaque psoriasis in 2010, based on evidence from two eight-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one eight-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was received in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.