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FDA approves LEO Pharma’s Picato gel

Wednesday, January 25, 2012 04:21 PM

The FDA has approved LEO Pharma’s Picato (ingenol mebutate) gel (0.015%, 0.05%) for the topical treatment of actinic keratosis (AK), a precancerous condition caused by cumulative sun exposure.

Two concentrations of the gel were approved: 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.

Studies show about 65% of squamous cell carcinomas begin as untreated actinic keratosis, and guidelines from the American Academy of Dermatology estimate 60% 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 of the department of dermatology at Mount Sinai Medical Center, New York, N.Y.  "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 saw complete clearance of AKs in the field of treatment as compared to placebo. The most common adverse events were local skin reactions, including erythema, flaking/scaling, crusting and swelling.

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