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FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Date:1/25/2012

eratosis on the face and scalp saw 75 percent or greater reduction of existing AKs (versus 7-8 percent with placebo), while 44-55 percent of patients with AKs on the trunk and extremities experienced 75 percent or more reduction (versus 7 percent reduction for placebo). Patients treated with Picato® gel saw 37-47 percent complete clearance of lesions on the face and scalp, and 28-42 percent on the trunk and extremities, versus up to 5 percent complete clearance with placebo in all studies. Local skin responses (LSRs) on the face and scalp were observed to peak around day 4 and resolve by day 15 in the majority of patients. LSRs on the trunk and extremities peaked around day 8 and markedly improved by day 29.

The most common adverse events were LSRs and included erythema, flaking/scaling, crusting and swelling. Other AEs occurring in ≥ 2 percent of subjects treated with Picato® gel include pain, pruritus and infection at the application site, as well as periorbital edema and headache.

IMPORTANT SAFETY INFORMATION
For topical use only; not for oral, ophthalmic, or intravaginal use. Eye disorders, including severe eye pain, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. Patients should wash hands well after applying Picato® gel, and avoid transfer of the drug to the periocular area during and after application. Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation/pustulation, and erosion/ulceration, can occur after application. Administration of Picato® gel is not recommended until the skin is healed from any previous drug or surgical treatment. The most common adverse reactions observed in clinical trials (greater than or equal to 2%) are local skin reactions, application site pain, application site pruritus, application site irritation, application site infection, periorbital edema, nasopharyngitis and headache. There are no adequate an
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SOURCE LEO Pharma Inc.
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