FDA announced approval of Sorilux Foam, which had previous approval for adults, for adolescents between the ages of 12 and 17.
The US Food and Drug Administration has approved calcipotriene (Sorilux) foam 0.005% for the treatment of plaque psoriasis in children 12 and older.
Calcipotriene, which is produced by Mayne Pharma Group Limited, was originally approved in 2010 for patients 18 and older, but a results of a recent open label study has led to the approval for treatment of plaque psoriasis of the scalp and body in patients between 12 and 17 years old.
“Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness,” said Scott Richards, chief executive officer at Mayne Pharma.
The approval of calcipotriene foam in 2010 was based on evidence from 2, 8-week placebo controlled clinical trials in patients who had mild to moderate plaque psoriasis of the body and 1, 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Additional data was obtained in a follow-up open-label study in patients between the ages of 12 and 17 years old with psoriasis. In the open-label study, 19 pediatric participants between 12 to and 17 years applied calcipotriene foam twice daily for 14 days and once on Day 15. Adverse reactions among participants included application site pain.
Calcipotriene foam is a synthetic vitamin D analog with a similar receptor binding infinity as natural vitamin D — the exact mechanism of action contributing to the clinical efficacy of calcipotriene is unknown.