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FDA approves actinic keratosis treatment


PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

Leo announced the FDA approval of Picato (ingenol mebutate) gel in the 0.015%/0.05% strength for actinic keratosis, also known as AK, which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma.

"Since there is no way to predict which actinic keratosis will advance to skin cancer, early detection and treatment of lesions are critical," said Mark Lebwohl of the Department of Dermatology at New York's Mount Sinai Medical Center and an investigator of a late-stage clinical trial of the drug. "What makes this new solution particularly exciting is the two- or three-day course of treatment."

According to the American Academy of Dermatology, 1-in-5 Americans will develop skin cancer in their lifetimes, and studies have shown that about 65% of cases of squamous cell carcinoma begin as untreated actinic keratosis.

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