EMA has completed its review of Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, and concluded that the medicine may increase the risk of skin cancer and that its risks outweigh its benefits.

The review looked at results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). After 3 years, 6.3% of patients treated with Picato (15 out of 240 patients) developed skin cancer, particularly squamous cell carcinoma, in the treated skin area compared with 2% of patients treated with imiquimod (5 out of 244 patients).

Data from other studies with ingenol mebutate or a similar medicine ingenol disoxate, laboratory studies and reports received since the medicine has been on the market were also assessed in the review.

It was noted that recent data from a study on the effectiveness of actinic keratosis treatments supported the previous observation, detailed in the medicine’s product information, that Picato’s effectiveness decreases over time.

Picato is no longer authorised in the EU as the marketing authorisation was withdrawn on 11 February 2020 at the request of LEO Laboratories Ltd, the company that marketed the medicine.

Posted on the EMA website on 30 April 2020