Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2019

6 September 2019

PRAC starts review of data on skin cancer with Picato

EMA’s safety 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.

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.

In order to conclude on whether Picato increases the risk of skin cancer, the PRAC will now carry out a thorough review of all available data, including from ongoing studies. The Committee will assess the impact of the data on the benefit-risk balance of Picato and recommend whether the medicine’s marketing authorisation in the EU should be amended.

Healthcare professionals are advised to use Picato with caution in patients who have had skin cancer in the past. In addition, patients should continue to watch out for any skin lesions and inform their doctor immediately if they notice anything unusual.

More information is available below.

Agenda

Agenda - PRAC draft agenda of meeting 2-5 September 2019

Draft Reference Number: EMA/PRAC/483724/2019

PRAC statistics: September 2019

PRAC statistics: September 2019

Glossary:

• Safety signal assessments. A safety signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature. More information can be found under 'Signal management'.
• Periodic safety update reports, abbreviated as PSURs, are reports prepared by the marketing authorisation holder to describe the worldwide safety experience with a medicine in a defined period after its authorisation. PSURs for medicinal products that contain the same active substance or the same combination of active substances, but have different marketing authorisations and are authorised in different EU Member States, are jointly assessed in a single assessment procedure. More information can be found under 'Periodic safety update reports: questions and answers'.
• Risk management plans, abbreviated as RMPs, are detailed descriptions of the activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicines. Companies are required to submit an RMP to EMA when applying for a marketing authorisation. RMPs are continually updated throughout the lifetime of the medicine as new information becomes available. More information is available under 'Risk-management plans'.
• Post-authorisation safety studies, abbreviated as PASSs, are studies carried out after a medicine has been authorised to obtain further information on its safety, or to measure the effectiveness of risk-management measures. The PRAC assesses the protocols (aspects related to the organisation of a study) and the results of PASSs. More information can be found under 'Post-authorisation safety studies'.
• Referrals are procedures used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral related to safety of medicines, the PRAC is requested by a Member State or the European Commission to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the EU. More information can be found under referral procedures.

Start of referral - Article-20 procedure

Article-20 procedure: Picato

Picato Article-20 referral - Review started

Reference Number: EMA/484093/2019

Picato Article-20 referral - Notification

Picato Article-20 referral - Timetable for the procedure

Reference Number: EMA/PRAC/484544/2019 Rev.1

Picato Article-20 referral - PRAC list of questions

Reference Number: EMA/PRAC/484308/2019

Ongoing referrals

Procedure	Status	Update
Article-31 procedure: Cyproterone-containing medicinal products	Under evaluation	PRAC continued its assessment
Article-31 procedure: Estradiol-containing (0.01% w/w) medicinal products for topical use	Under evaluation	PRAC adopted a list of experts for the ad-hoc expert group meeting
Article-31 procedure: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products	Under evaluation	PRAC continued its assessment
Article-20 procedure: Lemtrada	Under evaluation	PRAC continued its assessment
Article-31 procedure: Leuprorelin-containing depot medicinal products	Under evaluation	PRAC continued its assessment
Article-20 procedure: Xeljanz	Under evaluation	PRAC adopted a list of outstanding issues for marketing authorisation holders and a list of questions for the ad-hoc expert group