European Medicines Agency review of Picato concludes medicine’s risks outweigh its benefits

News Category: Regulatory news

Date: 21/04/2020

The EMA’s safety committee (PRAC) has confirmed that Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, may increase the risk of skin cancer and concluded that the risks of the medicine outweigh its benefits. The conclusions are based on a review of all available data on the risk of skin cancer in patients using Picato, including results of a study comparing Picato with imiquimod (another medicine for actinic keratosis).

Picato is no longer authorised in the EU. In January 2020, Picato was suspended as a precaution while the review was underway. On 11 February 2020, the marketing authorisation was withdrawn at the request of LEO Laboratories Ltd, the company that marketed the medicine.

Further details, including advice for patients, is available on the EMA website.

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