EU Panel Review Supports Decision to Pull Picato From Market

Megan Brooks

April 20, 2020

The European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded its safety review of ingenol mebutate (Picato), finding that the risks for skin cancer from the topical gel used to treat actinic keratosis outweigh the benefits.

Picato was cleared for marketing in the European Union in November 2012. The European Commission requested a safety review of the drug in September 2019 after data suggested a higher number of skin cancer cases, including cases of squamous cell carcinoma, in patients using it, as reported by Medscape Medical News.

In January 2020, use of Picato was suspended as a precaution while the PRAC review was underway. One month later, marketing authorization was withdrawn at the request of Leo Laboratories Ltd, which marketed the medicine.

The PRAC has now concluded its review of all available data on the risk for skin cancer in patients using Picato, including results of a study that compared Picato with imiquimod.

The review found "a higher occurrence of skin cancers, especially squamous cell carcinoma, in areas of skin treated with Picato than in areas treated with imiquimod," the EMA said Friday in a news release.

"The committee also considered that Picato’s effectiveness is not maintained over time and noted that other treatment options are available for actinic keratosis," the EMA said.

The agency recommends that patients who have used Picato watch for unusual skin changes or growths, which may occur weeks to months after use, and seek medical advice if any occur.

Picato continues to be available in the United States, although the US Food and Drug Administration is also looking into its safety and risks.

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