Factor VIII
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
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
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Approved name |
Factor VIII
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Associated names |
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Class |
-
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About this procedure
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Current status |
European Commission final decision
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Reference number |
EMEA/H/A-31/1448
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Type | |
Decision making model |
PRAC-CHMP-EC
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Authorisation model |
Centrally and nationally authorised products (mixed)
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Key dates and outcomes
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Procedure start date |
07/07/2016
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PRAC recommendation date |
01/09/2017
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CHMP opinion/CMDh position date |
14/09/2017
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EC decision date |
10/10/2017
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Outcome |
Risk minimisation measures
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All documents
Procedure started
Factor VIII Article-31 referral - Review started (PDF/76.84 KB)
First published: 08/07/2016
Last updated: 08/07/2016
EMA/472176/2016
Factor VIII Article-31 referral - PRAC list of questions (PDF/101.27 KB)
First published: 08/07/2016
Last updated: 08/07/2016
EMA/PRAC/471535/2016
Factor VIII Article-31 referral - Timetable for the procedure (PDF/72.95 KB)
First published: 08/07/2016
Last updated: 27/07/2017
EMA/PRAC/471536/2016
Factor VIII Article-31 referral - Notification (PDF/381.36 KB)
First published: 08/07/2016
Last updated: 08/07/2016
Recommendation provided by Pharmacovigilance Risk Assessment Committee
Factor VIII Article-31 referral - PRAC confirms its previous conclusion on risk of inhibitor development with factor VIII medicines (PDF/169.08 KB)
First published: 01/09/2017
Last updated: 01/09/2017
EMA/567277/2017
Factor VIII Article-31 referral - PRAC concludes there is no clear and consistent evidence of a difference in inhibitor development between classes of factor VIII medicines (PDF/175.08 KB)
First published: 05/05/2017
Last updated: 09/06/2017
EMA/153837/2017
European Commission final decision
Factor VIII Article-31 referral - Assessment report (PDF/239.88 KB)
First published: 05/12/2017
Last updated: 05/12/2017
EMA/763977/2017
Factor VIII Article-31 referral - Annex II (PDF/113.63 KB)
First published: 05/12/2017
Last updated: 05/12/2017
Factor VIII Article-31 referral - No clear and consistent evidence of difference in risk of inhibitor development between classes (PDF/90.76 KB)
First published: 15/09/2017
Last updated: 05/12/2017
EMA/603417/2017
Factor VIII Article-31 referral - Annex III (PDF/77.63 KB)
First published: 15/09/2017
Last updated: 04/12/2017
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
News
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15/09/2017
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15/09/2017
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01/09/2017
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09/06/2017
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05/05/2017
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13/01/2017
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28/10/2016
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30/09/2016
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02/09/2016
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08/07/2016