European Medicines Agency review of ingenol mebutate upholds marketing authorisation suspension following safety review

The EMA has concluded that the risks of using ingenol mebutate for actinic keratosis outweigh the benefits after a review concluded that the medicine increases the risk of squamous cell carcinoma, whilst effectiveness is not maintained over time.

SPS commentary:

The product license had previously been suspended in February pending a review of data comparing ingenol mebutate with imiquimod.


European Medicines Agency