European Haemophilia Consortium (EHC)

The European Haemophilia Consortium Welcomes You

EHC Annual Conference 2014 Evaluation: now available online

8 October 2014

Delegates who have attended the EHC 2014 Annual Conference and have not had the opportunity to complete their evaluation forms in their delegate packs, can now do the evaluation online via Survey Monkey. The Evaluation is composed of 10 questions and takes approximately 5 minutes to fill in. The EHC would like to thank all participants taking part in the evaluation.

EHC General Assembly selects new logo to mark the organisation's 25th anniversary

8 October 2014

During its last Annual Meeting held on Sunday 5 October, the EHC General Assembly selected a new logo to mark its 25th anniversary and the modernisation of the Organisation. The EHC visual identify will be updated with the new logo in the upcoming weeks.

EHC hosts its Annual General Assembly

6 October 2014

Following the European Haemophilia Consortium (EHC) 27th Annual Conference, the EHC held its Annual General Assembly. The EHC is pleased to announce the following decisions taken by its members:

  • The EHC welcomes the Public Association 'Community of handicapped - Haemophiliacs' from the Kyrgyz Republic as its 45th member.
  • The EHC congratulates Mr Jordan Nedevski from the Bulgarian National Member Organisation (NMO) for his re-election as EHC Vice-President Finance.
  • The EHC congratulates the Norwegian NMO for winning the bid to host the 2016 Annual Conference. The event will be held in Stavanger, Norway.
  • The EHC congratulates the Greek NMO for winning the 'survey raffle'. The raffle is open to all NMOs taking part in EHC surveys.

During the Annual General Assembly, the EHC also announced the dates of its 2015 activities:

  • Round Tables (held in Brussels, Belgium):
    • 2 March on 'Adverse Events and Inhibitors'
    • 15 June on 'Tenders and Procurement'
    • 12 October on 'Mild Haemophilia'
  • Workshops:
    • 3-5 July 'Youth Workshop' (location to be determined)
    • 11-13 September 'HTA and Economics' (St. Petersburg, Russian Federation)
    • 20-22 November 'New Technologies' (location to be determined)
  • The theme of World Haemophilia Day 2015 will be 'Tenders and Procurement'
  • The EHC will carry out a survey to review the state of haemophilia care in Europe (follow-up to the survey 'State of Haemophilia Care in 35 countries')
  • The EHC 2015 Annual Conference will be held on 2-3 October 2015 in Belgrade, Serbia. The conference will be preceded by a two-day Leadership Conference open to all EHC NMOs.

Additional details on all of these events will be posted on the EHC website and Facebook page and will be sent directly to the EHC Membership. For additional details, please contact Laura Savini at the EHC office (Write us a e-mail laura.savini-Entfernen Sie diesen or +32.893.24.73)

EHC hosts 27th Annual Conference in Belfast

6 October 2014

The European Haemophilia Consortium hosted its 27th Annual Conference in Belfast, Northern Ireland. Over 250 participants from 35 countries came together for a series of workshops, scientific sessions and symposiums. The EHC thanks all of those who attended and made possible the event including the Haemophilia Society, who kindly hosted the event.

Recombinant FVIII product associated with higher risk of inhibitor development in newly diagnosed, previously untreated patients with severe hemophilia A

4 October 2014

A study published in the journal Blood on September 24, 2014 suggests that inhibitor incidence is elevated in previously untreated patients (PUPs) with severe hemophilia A treated with Kogenate FS/Helixate Nexgen compared to other recombinant factor VIII (rFVIII) products. It should be noted that Kogenate FS/Helixate Nexgen have been marketed for over a decade and have a good safety record. No increased inhibitor risk has been found for previously treated patients (PTPs). The development of inhibitors is a known risk for all factor VIII products; however, this is the second study suggesting an increased risk with this specific product.

In January 2013, the Research of Determinants of Inhibitor Development (RODIN) study group reported an unexpected higher risk of inhibitor development in PUPs treated with this second-generation full-length rFVIII, Kogenate FS/Helixate Nexgen. That study was reviewed by regulators and in December 2013 the European Medicines Agency’s (EMA) Committee on Human Medicinal Products (CHMP) endorsed recommendations, which concluded that the benefits of Kogenate FS/Helixate NexGen continue to outweigh their risks in PUPs with hemophilia A. The CHMP also stated that the product information for these medicines should be amended to reflect the results of the RODIN study. The manufacturer initiated an update to their product label

The newly published study focused on 303 boys with severe hemophilia A first treated with a rFVIII product. The inhibitor incidence was higher with Kogenate FS/Helixate NexGen versus the most widely used rFVIII product. Similar results were found for high-titer inhibitors and in sensitivity analyses. The researchers believe these results suggest the higher immunogenicity of Kogenate FS/Helixate NexGen compared to other rFVIII products in newly diagnosed PUPs with severe hemophilia A.

The European Haemophilia Consortium (EHC) and the World Federation of Hemophilia (WFH)  have both requested that the  European Medicine Agency (EMA) examine all the relevant data in an expedited manner. Based on the available published data, it may be prudent, where other safe clotting factor concentrates are available, to consider not using Kogenate FS/Helixate NexGen for newly diagnosed PUPs with severe hemophilia A. There is no evidence of a higher risk of inhibitors with this product in PTPs.

Data related to the immunogenicity of treatment products is constantly evolving;  EHC and WFH supports the detailed and rapid publication of all relevant clinical and trial data to allow for a full and independent evaluation of the benefits and potential harms of treatment.  We will closely monitor this situation and will communicate again no later than November 17.

About the EHC

The EHC is an umbrella patient association of 44 national haemophilia associations in Europe. In this website you will find more about the bleeding disorders, about the mission and activities of the EHC, about its members and much more.

EHC Headquarters: rue de l'Industrie/ Nijverheidsstraat 10, 1000 Brussels, Belgium, tel: +32.(0)2.893.24.70 Write us a e-mail office-Entfernen Sie diesen