Denmark's LEO Pharma initiates Picato phase-out

Following safety warnings on Picato (ingenol mebutate) from regulators, including the European Medicines Agency and the US Food and Drug Administration, Danish drugmaker LEO Pharma yesterday announced it was initiating a phase-out for the product, a gel for the treatment of actinic keratosis, which is expected to be completed by year-end 2020 at the latest as follows:

In the USA, LEO Pharma provided the FDA with notification of the permanent discontinuation in the manufacture of Picato and the withdrawal of New Drug Application (NDA) 202833 as Picato will no longer be marketed.

In Australia, LEO Pharma has already informed wholesalers and prescribers about discontinuation of Picato and will be withdrawing the marketing authorization.