FDA expands indication for Sorilux to include adolescents with psoriasis

The FDA has approved Sorilux (calcipotriene) Foam, 0.005%, from Mayne Pharma, in adolescents. The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux 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 analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.