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news.Leo Pharma's Picato (ingenol mebutate) gel (0.015%, 0.05%) has gained US Food and Drug Administration (FDA) approval for the topical treatment of actinic keratosis (AK).
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Picato 0.015% gel is used once daily on the face and scalp for three consecutive days, and Picato 0.05% gel is used once daily on the trunk and extremities for two consecutive days.
The four phase III clinical studies reported that a significantly higher proportion of those treated with Picato gel showed complete clearance of AKs when compared to placebo.
LEO Pharma president and CEO John Koconis said the approval of Picato gel in the US is another step forward in helping them realize the vision of becoming a preferred dermatology care partner worldwide.
"We are pleased to introduce Picato gel, a new treatment option for patients with actinic keratosis, a common precancerous condition," Koconis added.
Actinic keratosis is a dry, scaly, rough-textured patch or lesion that forms on the outermost layer of the skin following cumulative exposure to ultraviolet light.