EMA/PRAC starts review of data on skin cancer with Picato

6 September 2019

European Medicines Agency’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of data on skin cancer in patients using Picato (ingenol mebutate), a gel for treating actinic keratosis, a skin condition caused by too much sunlight exposure, it was announced following its meeting over September 2-5.

Picato is a drug from independent Danish drugmaker LEO Pharma that received approval from the the US Food and Drug Administration in January 2012 and in Europe in November of that year

The review was triggered by data from several studies showing a higher number of skin cancer cases including cases of squamous cell carcinoma in patients using Picato.

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