Picato

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CHMP opinion
  • European Commission final decision
Current status:
Under evaluation

Overview

EMA suspends Picato as a precaution while review of skin cancer risk continues

On 16 January 2020, EMA recommended that patients stop using Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, while it continues its review of the medicine’s safety.

EMA’s safety committee (PRAC) is currently reviewing data on skin cancer in patients using Picato. Final results from a study comparing Picato with imiquimod (another medicine for actinic keratosis) indicate a higher occurrence of skin cancer in the treatment area with Picato than with imiquimod. 

While uncertainties remain, there is concern about a possible link between the use of Picato and the development of skin cancer. The PRAC therefore recommended suspending the medicine’s marketing authorisation as a precaution and noted that alternative treatments are available. 

The PRAC will continue its review and when the review has concluded, EMA will provide updated guidance to patients and healthcare professionals. 

Key facts

About this medicine
Approved name
Picato
International non-proprietary name (INN) or common name

ingenol mebutate

Associated names
Picato
About this procedure
Current status
Under evaluation
Reference number
EMEA/H/A-20/1489/C/2275/1489
Type
Article 20 procedures

This type of procedure is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally authorised product(s)
Key dates and outcomes
Procedure start date
05/09/2019
PRAC recommendation date
16/01/2020
Outcome
Suspension

All documents

Procedure started

Under evaluation

Document description

  • Annex I - List of the medicines affected by the referral
  • Annex II - Scientific conclusions of the CHMP or CMDh
  • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
  • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
  • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
  • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
  • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
  • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
  • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

News

How useful was this page?

Add your rating