EMA Safety Panel Finds Actinic Keratosis Drug Can Increase Risk of Skin Cancer

The EMA’s Pharmacovigilance Risk Assessment Committee said that the risks of LEO Laboratories’ Picato (ingenol mebutate) for treatment of actinic keratosis outweigh the benefits because of the increased risk of skin cancer.

The safety panel noted a higher occurrence of skin cancers in areas of skin treated with Picato than in areas treated with another actinic keratosis treatment, imiquimod. It also noted that Picato’s benefit is not maintained over time, and that other treatment options are available.

Picato was suspended in January pending the results of the EMA’s review, and the company withdrew its marketing authorization on Feb. 11.