LEO Pharma initiates phase-out of Picato®

Ballerup, Denmark, October 27, 2020: LEO Pharma A/S today announced that, based on an overall busi-ness assessment of the product, the company is initiating a phase-out of Picato® (ingenol mebutate) gel for treatment of actinic keratosis.

The phase-out follows the voluntary withdrawal of Picato® in the EU and EEA earlier this year. The phase-out is expected to be completed by year-end 2020 at the latest as follows:

In the U.S., LEO Pharma provided FDA with notification of the permanent discontinuation in the manufacture of Picato and the withdrawal of NDA 202833 as Picato® will no longer be marketed.

In Australia: LEO Pharma has already informed wholesalers and prescribers about discontinuation of Pi-cato® and will be withdrawing the marketing authorization.

In Canada, LEO Pharma has initiated a recall of Picato® on October 26, 2020. Health Canada conducted a safety review of available evidence for Picato®, including scientific and medical literature, and benefit-risk analysis, and determined that the evidence submitted is not sufficient to establish the safety and effective-ness of Picato® under the conditions of use recommended.

Patient safety is LEO Pharma's highest priority. LEO Pharma's assessment of the benefit/risk balance for Picato® remains unchanged and favorable.

LEO Pharma will continue to work collaboratively with regulatory authorities in relation to the recall and with-drawal of the product in a fully transparent manner.

LEO Pharma remains committed to patient safety, pharmacovigilance and full data transparency, and will continue to focus on providing safe products to the patients the company serves.

Patients currently using Picato® should consult with their health care professional for guidance on other available treatments for actinic keratosis.

Patients should report to their doctor signs and symptoms of skin cancer such as scaly red patches, open sores, elevated or warty growths within the treatment area (as per currently approved product monograph).

LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit.

Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million.


Trine Juul Wengel

Global External Communication
Tel: +45 2073 2037