Picato is an ingenol mebutate gel to treat an excessively sun exposed skin condition called keratosis. The Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA has begun reviewing data on skin cancer in patients using Picato.

With prevailing cases of patients with squamous cell carcinoma using Picato as revealed in several studies on skin cancer, the EMA has instigated the decision to run the review on Picato patient skincare data until January of 2020. PRAC is also expecting LEO pharma to help the review process with information on Picato exposure to the cumulative patients across the globe.