Leo Pharma withdraws Picato, a treatmemt for actinic keratosis, in the EU.

The European Medicines Agency (EMA) has recommended 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 authorization, which is expected to lead to a withdrawal of Picato in the EU and EEA.