EMA’s safety committee (PRAC) recommended that patients stop using Picato (ingenol mebutate) manufactured by LEO Pharma, a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.
The PRAC is currently reviewing data on skin cancer in patients using Picato. While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer.
Once the PRAC review is concluded, the final recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
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