Esmya

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

Overview

 

Esmya: new measures to minimise risk of rare but serious liver injury

EMA concludes review of medicine for uterine fibroids

On 31 May 2018, the European Medicines Agency (EMA) recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (ulipristal acetate). Certain women may start treatment with Esmya once the new measures are implemented.
The measures include: contraindication in women with known liver problems; liver tests before, during and after stopping treatment; a card for patients to inform them about the need for liver monitoring and to contact their doctor should they develop symptoms of liver injury. In addition, use of the medicine for more than one treatment course has been restricted to women who are not eligible for surgery.
Esmya is used to treat moderate to severe symptoms of uterine fibroids (benign tumours of the womb). The medicine has been shown to be effective at reducing bleeding and anaemia associated with the condition, as well as the size of the fibroids.
The review of Esmya was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) following reports of serious liver injury, including liver failure leading to transplantation. The PRAC concluded that Esmya may have contributed to the development of some cases of serious liver injury.1
The PRAC therefore recommended that use of the medicine should be restricted. It also recommended that studies should be performed to determine the effects of Esmya on the liver and whether the new measures are effective in minimising the risks.
The PRAC's recommendations were endorsed by EMA's Committee for Medicinal Products for Human Use (CHMP) and sent to the European Commission for a final legal decision. A letter was sent to doctors to inform them of the new conditions of use.


1In 8 cases of serious liver injury, a role of Esmya in contributing to these cases is possible. It is estimated that around 765,000 patients have been treated with Esmya to date.

Key facts

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

ulipristal acetate

Associated names
Esmya
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-20/1460/C/2041/0043
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
30/11/2017
PRAC recommendation date
17/05/2018
CHMP opinion/CMDh position date
31/05/2018
EC decision date
26/07/2018
Outcome
Risk minimisation measures

All documents

Procedure started

Under evaluation

  • List item

    Esmya Article-20 procedure - Assessment report on provisional measures (PDF/276.07 KB)


    First published: 21/02/2018
    Last updated: 21/02/2018

  • List item

    Esmya Article-20 procedure - Scientific conclusions (PDF/45.11 KB)


    First published: 21/02/2018
    Last updated: 21/02/2018

  • List item

    Esmya Article-20 procedure - Annex I-II-III (PDF/256.42 KB)


    First published: 09/02/2018
    Last updated: 20/02/2018

  • List item

    Esmya Article-20 procedure - Women taking Esmya for uterine fibroids to have regular liver tests while EMA review is ongoing (PDF/88.21 KB)


    First published: 09/02/2018
    Last updated: 09/03/2018
    EMA/76828/2018

  • Recommendation provided by Pharmacovigilance Risk Assessment Committee

    Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Esmya Article-20 procedure - Esmya: new measures to minimise risk of rare but serious liver injury (PDF/90.45 KB)


    First published: 08/08/2018
    Last updated: 08/08/2018
    EMA/482522/2018

  • List item

    Esmya Article-20 procedure - PRAC assessment report (PDF/271.51 KB)


    First published: 08/08/2018
    Last updated: 08/08/2018
    EMA/442745/2018

  • List item

    Esmya Article-20 procedure - Esmya: new measures to minimise risk of rare but serious liver injury (PDF/90.45 KB)


    First published: 08/08/2018
    Last updated: 08/08/2018
    EMA/482522/2018

  • List item

    Esmya Article-20 procedure - PRAC divergent position (PDF/49.54 KB)


    First published: 08/08/2018
    Last updated: 08/08/2018

  • List item

    Esmya Article-20 procedure - Annex IV (PDF/48.79 KB)


    First published: 08/08/2018
    Last updated: 08/08/2018

  • List item

    Esmya Article-20 procedure - CHMP divergent position (PDF/49.4 KB)


    First published: 08/08/2018
    Last updated: 08/08/2018

  • 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

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