European Medicines Agency (EMA) review finds risks of Ingenol mebutate (Picato) for actinic keratosis outweigh benefits

Review compared Picato with imiquimod. After 3 years, 6.3% of patients treated with Picato (15/240) developed skin cancer, particularly squamous cell carcinoma, in the treated skin area vs. 2% of imiquimod patients (5/244 patients).

SPS commentary:

Picato is no longer authorised in the EU as the marketing authorisation was withdrawn on 11 February 2020 at the request of the company that marketed the medicine.


European Medicines Agency