Factor VIII

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

Overview


Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes

EMA concludes review of human factor VIII medicines authorised in EU

The European Medicines Agency (EMA) has concluded that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: those derived from plasma and those made by recombinant DNA technology.

EMA's review was started following publication of the SIPPET study (1), which concluded that recombinant factor VIII medicines had a higher incidence of inhibitor development than plasma-derived medicines. The review also covered other relevant interventional clinical trials and observational studies. When all these data were examined, they did not provide clear evidence of a difference in risk of inhibitor development between the two classes of medicines.

Factor VIII is needed for blood to clot normally and is lacking in patients with haemophilia A. Factor VIII medicines replace the missing factor VIII and help control and prevent bleeding. However the body may develop inhibitors as a reaction to these medicines, particularly when patients first start treatment. The inhibitors reduce the medicines' effect, so bleeding is no longer controlled.

Due to the different characteristics of individual products within the two classes, EMA concluded that the risk of inhibitor development should be evaluated individually for each medicine, regardless of class. The risk for each product will continue to be assessed as more evidence becomes available.

To reflect current knowledge, the prescribing information of factor VIII medicines will be updated to include, as appropriate, inhibitor development as a very common side effect in previously untreated patients, and as an uncommon side effect in previously treated patients. The warning on inhibitor development will be amended to state that low levels of inhibitors pose less risk of severe bleeding than high levels.

Key facts

About this medicine
Approved name
Factor VIII
Associated names
  • Iblias
  • Elocta
  • Kovaltry
  • Nuwiq
  • Obizur
  • NovoEight
  • Voncento
  • ReFacto AF
  • Kogenate Bayer
  • Helixate NexGen
  • Advate
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1448
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CHMP-EC
Authorisation model
Centrally and nationally authorised products (mixed)
Key dates and outcomes
Procedure start date
07/07/2016
PRAC recommendation date
01/09/2017
CHMP opinion/CMDh position date
14/09/2017
EC decision date
10/10/2017
Outcome
Risk minimisation measures

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

European Commission final decision

  • List item

    Factor VIII Article-31 referral - Assessment report (PDF/239.88 KB)

    Adopted

    First published: 05/12/2017
    Last updated: 05/12/2017
    EMA/763977/2017

  • List item

    Factor VIII Article-31 referral - Annex II (PDF/113.63 KB)


    First published: 05/12/2017
    Last updated: 05/12/2017

  • List item

    Factor VIII Article-31 referral - No clear and consistent evidence of difference in risk of inhibitor development between classes (PDF/90.76 KB)

    Adopted

    First published: 15/09/2017
    Last updated: 05/12/2017
    EMA/603417/2017

  • List item

    Factor VIII Article-31 referral - Annex III (PDF/77.63 KB)


    First published: 15/09/2017
    Last updated: 04/12/2017

  • List item

    Factor VIII Article-31 referral - Annex I (PDF/391.49 KB)


    First published: 08/07/2016
    Last updated: 05/12/2017

  • 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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