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FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Date:1/25/2012

PARSIPPANY, N.J., Jan. 25, 2012 /PRNewswire/ -- LEO Pharma announced today that the U.S. Food and Drug Administration (FDA) approved Picato® (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK). AK is a precancerous condition caused by cumulative sun exposure that has the potential to progress to squamous cell carcinoma (SCC), the second most common type of skin cancer.[1],[2] 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.[3] Picato® gel is the first and only topical AK therapy that can be used for as little as two or three days.

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According to the American Academy of Dermatology (AAD), 1 in 5 Americans will develop skin cancer in the course of their lifetime.[4] Studies show that about 65 percent of squamous cell carcinomas begin as untreated actinic keratosis,[5] and guidelines from the AAD estimate that 60 percent of predisposed persons older than 40 have at least one actinic keratosis.[6]  

"Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical," said ingenol mebutate study investigator Dr. Mark Lebwohl, Department of Dermatology, Mount Sinai Medical Center, New York, New York.  "What makes this new solution particularly exciting is the two or three day course of treatment." 

In four phase III clinical studies of more than 1,000 patients with actinic keratosis, a significantly higher proportion of those treated with Picato® gel (n=503) saw complete clearance of AKs in the field of treatment as compared to placebo (n=502). The most common adverse events (AEs) were local skin reactions (LSRs), including
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SOURCE LEO Pharma Inc.
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