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GEN News Highlights : Jan 26, 2012

FDA Clears Leo’s Picato Gel for 2–3 Day Treatment of Actinic Keratosis

Phase III trial for Euphorbia plant-derived drug included 1,000 patients.

FDA approved Leo Pharma’s Picato® (ingenol mebutgate) gel for the treatment of actinic keratoses (AK) lesions on the face, scalp, trunk, and extremities. The once-daily topical gel has been is available in two concentrations, 0.05%, and 0.015%, and is used for two days as a treatment for AK on the trunk and extremities (0.05% concentration), and for three days on the face and scalp (0.015% concentration).

Regulatory clearance in the U.S. was based on data from four Phase III studies involving 1,000 patients, which demonstrated that ingenol mebutate therapy was significantly more effective than placebo at clearing actinic keratoses. The data showed that 60% to 68% of patients with actinic keratosis on the face and scalp, and 44–55% of those with trunk/extremities lesions, experienced 75% or greater reduction of existing AKs after treatment with Picato, compared with 7–8% of placebo patients.

Ingenol mebutate is derived from the plant Euphorbia peplus, and is produced using an extraction, purification, and crystallization process that takes five months, Leo explains. For the manufacture of Picato gel, a selected cultivar of Euphorbia peplus plant is grown for LEO Pharma in Queensland, Australia.