BRIEF—EMA confirms Picato risks outweigh its benefits

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committe (PRAC) has confirmed that Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, may increase the risk of skin cancer and concluded that the risks of the medicine outweigh its benefits.

The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis). The study showed a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod.

The Committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis.

Picato is no longer authorised in the EU. In January 2020, Picato was suspended as a precaution while the review was underway. On 11 February 11, 2020, the marketing authorization was withdrawn at the request of Denmark’s LEO Pharma, the company that marketed the medicine.