Pharmaceutical company Mayne Pharma Group Limited (ASX:MYX) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for SORILUX (calcipotriene) Foam, 0.005%, for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.
Plaque psoriasis is a chronic, non-contagious, inflammatory skin condition that appears as red patches covered with silvery flakes often found on the elbows, scalp and knees but can also affect other parts of the body.
According to the company, SORILUX Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. It is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients aged 12 years and older.
The FDA originally approved SORILUX in 2010 based on evidence from the company's two, eight-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body plus one, eight-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp.
The further data was obtained in the company's follow-on open label study in patients aged 12 to 17 years of age with psoriasis.
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