WFH NETWORK

WFH statements, advisories, and letters

2014

Third publication suggests recombinant FVIII product associated with higher risk of inhibitor development in newly diagnosed, previously untreated patients with severe hemophilia A
November 17, 2014 (updated March 2015)  — The WFH has requested that the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA) examine all the relevant data and come to a conclusion as soon as possible. Click here >


Recombinant FVIII product associated with higher risk of inhibitor development in newly diagnosed, previously untreated patients with severe hemophilia A
October 3, 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/Bayer/Helixate Nexgen compared to other recombinant factor VIII (rFVIII) products. Click here >


WFH communique - Ebola hemorrhagic fever outbreak
August 2014 — An outbreak of the blood-borne disease Ebola hemorrhagic fever (Ebola HF, also called Ebola virus disease or EVD) is ongoing in several African countries. The outbreak has been categorized by the World Health Organization (WHO) as a serious public health emergency. Click here >


CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen 
January 2014 — Benefits continue to outweigh risks in previously untreated patients. The European Medicines Agency’s Committee on Human Medicinal Products (CHMP) has agreed by consensus to endorse recent recommendations. Click here >


Updated December 2015