FDA OKs ingenol mebutate for AK treatment

February 1, 2012

The Food and Drug Administration has approved Picato gel (ingenol mebutate, Leo Pharma) as a treatment for actinic keratoses on the face, scalp, trunk and extremities.

Washington - The Food and Drug Administration has approved Picato gel (ingenol mebutate, Leo Pharma) as a treatment for actinic keratoses on the face, scalp, trunk and extremities.

Picato gel is a once-daily, field-directed topical therapy that enables treatment of an area affected by AKs. For treatment of the face and scalp, the gel is applied at a concentration of 0.015 percent once daily, for three consecutive days; for body sites it is applied at 0.05 percent, once daily for two consecutive days.

Approval was based on data from four phase 3 studies involving more than 1,000 patients. Results showed that ingenol mebutate applied once daily for two or three consecutive days is significantly more effective than placebo at clearing AKs. The most common local skin reactions included erythema, flaking/scaling, crusting and swelling. Other adverse effects, occurring in 2 percent of subjects, included pain, pruritus and infection at the application site, as well as periorbital edema and headache when applied on face or scalp.

Leo Pharma officials say they expect Picato to be available to U.S. physicians in March.

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