LEO Pharma receives FDA approval for Picato topical gel to treat AK

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. 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. Picato® gel is the first and only topical AK therapy that can be used for as little as two or three days.

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

"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>

"LEO Pharma is committed to helping people achieve healthy skin. We are pleased to introduce Picato® gel, a new treatment option for patients with actinic keratosis, a common precancerous condition," said John Koconis, President and CEO, LEO Pharma Inc. "The approval of Picato® gel in the United States is another step forward in helping us realize our vision of becoming a preferred dermatology care partner worldwide."