Picato Gel Approved for Actinic Keratoses
PICATO (ingenol mebutate) 0.015%, 0.05% gel by LEO Pharma
LEO Pharma announced that the FDA has approved Picato (ingenol mebutate gel) for the topical treatment of actinic keratosis. This approval was based on data from four Phase 3 clinical studies of more than 1,000 patients with actinic keratosis (AK). Study data showed that a significantly higher proportion of those treated with Picato gel saw complete clearance of AKs in the field of treatment as compared to placebo. Approximately 60–68% of patients with AK on the face and scalp saw ≥75% reduction of existing AKs (versus 7–8% with placebo), while 44–55% of patients with AKs on the trunk and extremities experienced ≥75% reduction (versus 7% reduction for placebo). Patients treated with Picato gel saw 37–47% complete clearance of lesions on the face and scalp, and 28–42% on the trunk and extremities, versus up to 5% complete clearance with placebo in all studies.
Picato gel is expected to be available in March in 0.015% and 0.05% concentrations. Picato 0.015% is applied once daily for three consecutive days and is supplied in a carton with three unit dose laminate tubes. Picato 0.05% is applied once daily for two consecutive days and is supplied in a carton with two unit dose laminate tubes.For more information call (877) 494-4536 or visit www.leo-pharma.us.