Kogenate Bayer and Helixate NexGen

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

Overview

 

CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen

Benefits continue to outweigh risks in previously untreated patients

On 20 December 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) endorsed previous recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended. The recommendations, issued by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), resulted from a review of the medicines which did not confirm a higher risk of developing a type of antibody (factor VIII inhibitors) against these medicines when compared with other factor VIII products. Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.

The review by the PRAC was triggered by results from a study (the RODIN/PedNet study1) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS). About a third of all the children in the RODIN study developed factor VIII inhibitors against their medicine, which reduces the benefit and makes bleeding more likely. This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation full-length recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product. An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.

After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products. Although existing measures to minimise all the risks from using the products were considered adequate for both Kogenate Bayer and Helixate NexGen and should be continued, the PRAC recommended that the product information should be updated to reflect results from the RODIN study.

The CHMP considered the PRAC recommendations and agreed by consensus that they should be implemented. The CHMP opinion was then sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.


1Gouw SC, et al; PedNet and RODIN Study Group. Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.

Key facts

About this medicine
Approved name
Kogenate Bayer and Helixate NexGen
International non-proprietary name (INN) or common name
octocog alfa
Class
-
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/C/275/A20/150, EMEA/H/C/276/A20/143
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
07/03/2013
PRAC recommendation date
05/12/2013
CHMP opinion/CMDh position date
19/12/2013
EC decision date
20/02/2014
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen (PDF/90.22 KB)

    Adopted

    First published: 20/12/2013
    Last updated: 09/04/2014
    EMA/781158/2013

  • List item

    Helixate NexGen Article-20 procedure - Annex III (PDF/621.8 KB)


    First published: 20/12/2013
    Last updated: 20/12/2013

  • List item

    CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen (PDF/90.22 KB)

    Adopted

    First published: 20/12/2013
    Last updated: 09/04/2014
    EMA/781158/2013

  • List item

    Kogenate Bayer Article-20 procedure - Annex III (PDF/1.28 MB)


    First published: 20/12/2013
    Last updated: 20/12/2013

  • European Commission final decision

  • List item

    Helixate NexGen Article-20 procedure - Product information (PDF/703.36 KB)


    First published: 09/04/2014
    Last updated: 09/04/2014

  • List item

    Kogenate Bayer Article-20 procedure - Product information (PDF/1.45 MB)


    First published: 09/04/2014
    Last updated: 09/04/2014

  • List item

    Kogenate Bayer and Helixate NexGen Article-20 procedure - PRAC assessment report (PDF/163.99 KB)

    Adopted

    First published: 09/04/2014
    Last updated: 09/04/2014
    EMA/10430/2014

  • List item

    Kogenate Bayer and Helixate NexGen Article-20 procedure - Annex IV (PDF/39.53 KB)


    First published: 09/04/2014
    Last updated: 09/04/2014

  • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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