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.