LEO Pharma initiates voluntary withdrawal of marketing authorization and possible voluntary withdrawal of Picato® in the EU and EEA. Marketing of Picato® continues in US and elsewhere

[UPDATE, January 17, 2020: The European Medicines Agency (EMA) has today recommend-ed the suspension of Picato® in the EU and EEA as a precautionary measure as part of the ongoing article 20 referral process of the Pharmacovigilance Risk Assessment Committee (PRAC). The reason being that PRAC considers the benefit/risk balance of Picato® to be unfavorable.

LEO Pharma disagrees with the assessment of PRAC. LEO Pharma’s assessment of the benefit/risk balance for Picato® remains unchanged and favorable. The company will therefore continue to market Picato® in countries outside the EU and EEA. However, as it would not be commercially viable to re-launch the product in the EU and EEA after a long suspension, the company has initiated a voluntary withdrawal of the marketing authoriza-tion, which is expected to lead to a withdrawal of Picato® in the EU and EEA. UPDATE ENDS]

Ballerup, Denmark, January 9, 2020: LEO Pharma today announced that the company is initiating a voluntary withdrawal of its marketing authorization for Picato® (ingenol mebutate) gel for treatment of actinic keratosis in the EU and EEA. This will possibly lead to a withdrawal of Picato® from the EU and EEA markets.

The voluntary withdrawal is not linked to any new incidents of adverse events, customer complaints or quality effects.

The decision is based on an assessment of the impact on the commercial viability of Picato^® in the EU and EEA, following the ongoing article 20 referral process of the European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC).

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.

LEO Pharma has carefully reviewed the information received from PRAC, and the company disagrees with the ongoing assessment of PRAC. There is no additional safety data and it is LEO Pharma’s position that there is no evidence of a causal relationship or plausible mechanism hypothesis between the use of Picato^® and the development of skin malignancies.

LEO Pharma’s assessment of the benefit/risk balance for Picato^® remains unchanged and favorable, and the company will therefore continue to market Picato^® in countries outside the EU and EEA. Since its launch in 2012, there has been approximately 2.8 million Picato^® treatment courses.

LEO Pharma will continue to work collaboratively with EU and EEA regulatory authorities in relation to the withdrawal of the product, and with regulatory authorities worldwide in a fully transparent manner.

Patients currently using Picato^® in the EU/EEA should consult with their health care professional for guidance on other available treatments for actinic keratosis.