WFH NETWORK

Corporate Partners News 

This section of the World Federation of Hemophilia (WFH) website is for manufacturers to post press releases of interest to the hemophilia community. Information posted here does not represent an endorsement of a particular product by the WFH. Statements and opinions expressed here do not necessarily represent the opinions, policies, or recommendations of the WFH.


Bayer’s Jivi® approved in Japan for hemophilia A 
BERLIN, September 21, 2018—Bayer announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Jivi® (BAY94-9027) for the prophylactic treatment of hemophilia A for adults and adolescents 12 years of age or older in Japan. PDF


Bayer receives US approval for modern hemophilia A treatment Jivi® with a step-wise prophylaxis dosing regimen 
BERLIN, August 30, 2018—Bayer announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older in the U.S. PDF


Working to Improve Hemophilia A Testing: Precision BioLogic presents new data at the 64th Annual SSC meeting 
HALIFAX, July 19, 2018—Precision BioLogic today unveiled data from a study using a new kit for a Modified Nijmegen-Bethesda Assay (MNBA) at the International Society on Thrombosis and Haemostasis’ Scientific and Standardization Committee (SSC) meeting in Dublin. PDF


Bioverativ Presents Preliminary Phase 1/2a Data on BIVV001, the First Factor VIII Therapy to Break Through the VWF Half-life Ceiling in Hemophilia A
WALTHAM, Mass. – May 21, 2018 - Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, today presented initial clinical data for BIVV001 (rFVIIIFc-VWF-XTEN), a novel and investigational von Willebrand factor (VWF)-independent factor VIII therapy for people with hemophilia A. PDF


Bioverativ Highlights the Impact of Humanitarian Aid in Hemophilia — More than 15,000 people with hemophilia in 40 developing countries have already been treated following Bioverativ and Sobi’s unprecedented donation of factor therapy to the WFH Humanitarian Aid Program 
WALTHAM, Mass. , April 17, 2018 — Bioverativ Inc., a Sanofi company dedicated to transforming the lives of people with rare blood disorders, joins the global hemophilia community in recognizing World Hemophilia Day 2018. To honor this year’s theme, Sharing Knowledge Makes Us Stronger, Bioverativ is sharing the stories of people with hemophilia in the developing world and highlighting the life-changing impact treatment can make. PDF


Precision BioLogic Lights It Up Red in Support of World Hemophilia Day 
HALIFAX, April 17, 2018 — 
Precision BioLogic is pleased to support the World Federation of Hemophilia (WFH) and World Hemophilia Day. In recognition of World Hemophilia Day 2018, Precision BioLogic is lighting its offices up in red and encouraging everyone to visit the WFH eLearning Platform to learn more about hemophilia and other bleeding disorders. PDF


Grifols donates over 25 million international units of blood clotting factor in 2017 – Part of an eight-year commitment to WFH; Changing the lives of people with hemophilia in 47 countries with limited access to treatment
Barcelona, Spain (April 16, 2018) — Today, Grifols, S.A. (MCE:GRF, MCE:GRF.P and NASDAQ:GRFS) announced it has donated over 25 million international units(IU) of blood clotting factor medicines over the last year.This donation is part of Grifols’ commitment to provide a minimum of 200M IU to the World Federation of Hemophilia (WFH) Humanitarian Aid Program over eight years starting in 2014. An estimated 400,000 people around the world have hemophilia, yet only 25% receive adequate treatment. PDF


Precision BioLogic Presents New Approach to Standardize and Improve Inhibitor Testing for People with Hemophilia A
HALIFAX, March 13, 2018 – 
Precision BioLogic, in collaboration with Roche and Genentech, a member of the Roche Group, unveiled data from the study of a new kit for a modified Nijmegen-Bethesda Assay (MNBA) at the Thrombosis & Hemostasis Societies of North America (THSNA) summit in San Diego, California last week. Recognizing the need to standardize and improve Factor VIII (FVIII) inhibitor testing for people with hemophilia A, the companies collaborated on the development of the new MNBA kit and the recent study. PDF


New Data Show Extended Prophylactic Dosing with ALPROLIX® Provides Safe and Effective Protection in People with Severe Hemophilia B
ATLANTA – December 11, 2017 – Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) today announced the results of a new, post-hoc longitudinal analysis demonstrating that individualized dosing with extended half-life therapy, ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], every 14 or more days may be a potential option for people with severe hemophilia B who seek the benefits of protection from a prophylactic therapy with reduced treatment burden. PDF


Study Shows Weekly Prophylactic Treatment with ELOCTATE® Resulted in Bleed Protection and Target Joint Resolution in People with Hemophilia A 
ATLANTA– December 10, 2017 – Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) today announce the results of a new, post-hoc, longitudinal analysis of the pivotal Phase 3 A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its extended half-life therapy ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, has the potential to provide improved bleed protection over episodic treatment, resolve target joints and reduce the treatment burden associated with more frequent dosing intervals. PDF


ALPROLIX® Demonstrates Higher Tissue Distribution and Retention in Joints Compared to Other Factor IX Molecules in a Preclinical Imaging Study
ATLANTA – December 9, 2017 – Bioverativ Inc. (NASDAQ: BIVV), a global biopharmaceutical company dedicated to transforming the lives of people with rare blood disorders, today announced findings from a novel imaging study investigating extravascular distribution of factor IX therapies, including its leading extended half-life therapy, ALPROLIX® [Antihemophilic Factor IX (Recombinant), Fc Fusion Protein]. PDF


FDA approves Roche’s Hemlibra (emicizumab-kxwh) for haemophilia A with inhibitors
Basel, 16 November 2017 – Roche today announced that the US Food and Drug Administration (FDA) has approved Hemlibra® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. PDF


Interim Data Published in Haemophilia Show Improvements in Long-Term Joint Health for Hemophilia A Patients Following Prophylactic Treatment with ELOCTATE®
WALTHAM, Mass. & STOCKHOLM, Sweden – October 31, 2017 – Bioverativ Inc. (NASDAQ: BIVV) and Swedish Orphan Biovitrum AB (publ) (SobiTM) (STO:SOBI) today announced the publication of interim results from a longitudinal study of joint health in patients treated prophylactically with ELOCTATE® [Antihemophilic Factor (Recombinant), Fc Fusion Protein], marketed as Elocta® in Europe and the Middle East, for treatment of hemophilia A. PDF


Roche announces positive interim results for emicizumab in phase III study of children with haemophilia A 
Basel, 17 April 2017 - Roche announced today interim results from the phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with haemophilia A and inhibitors to factor VIII. PDF


Grifols Donates 140 Million International Units of Blood Clotting Factors to the World Federation of Hemophilia Humanitarian Aid Program
April 17, 2017 – Today, Grifols, announced that it will donate a minimum of 140 million international units (IU) of blood clotting factor medicines (Factor VIII) to the World Federation of Hemophilia (WFH) Humanitarian Aid Program over the next five (5) years. This announcement is a continuation of the Company’s three-year commitment from 2014, bringing the total humanitarian aid commitment to more than 200M IU of Factor VIII over eight years. PDF


Improving Access to Lifesaving Treatments for Bleeding Disorders in the Developing World 
April 10, 2017 –
The World Federation of Hemophilia (WFH) and global biotherapeutics leader CSL Behring announced today that CSL Behring has shipped more than 4 million international units (IUs) of its medicines to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program in recognition of World Hemophilia Day. PDF


Bioverativ Launches as Global Biotechnology Company Dedicated to Meaningful Progress in Hemophilia 
Waltham, Mass. – February 1, 2017 – Today, Bioverativ Inc. (NASDAQ: BIVVV) launches as an independent, global biotechnology company focused on the discovery, development, and commercialization of innovative therapies for hemophilia and other rare blood disorders. PDF


Novo Nordisk to present 28 abstracts at the World Federation of Hemophilia Congress 
Bagsværd, Denmark, 11 July 2016 – Novo Nordisk announced today that data from 28 abstracts will be shared at the upcoming WFH Congress in Orlando, Florida, from 24 to 28 July. The WFH Congress is the largest international meeting for the global bleeding disorders community, taking place every second year. PDF


U.S. FDA Approves CSL Behring’s AFSTYLA®--The First and Only Recombinant Factor VIII Single Chain Therapy for Hemophilia A
KING OF PRUSSIA, Pa., May 26, 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved AFSTYLA® [Antihemophilic Factor (Recombinant), Single Chain], its novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A. PDF


European Commission Approves IDELVION®  –  CSL Behring’s Novel Hemophilia B Treatment with Up to 14-day Dosing Intervals 
MARBURG, Germany – May 11, 2016 – CSL Behring announced today that the European Commission has approved IDELVION® [albutrepenonacog alfa], its innovative, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). PDF


CSL Behring Marks World Hemophilia Day by Donating IUs of Its Specialty Biotherapeutics for Bleeding Disorders to World Federation of Hemophilia 

MONTREAL and KING OF PRUSSIA, Pa. – April 13, 2016 – “Treatment for All is the Vision for All” is the WFH global message for World Hemophilia Day this year (April 17, 2016). The WFH and global biotherapeutics leader CSL Behring announced today that CSL Behring has shipped more than 1.5 million international units (IUs) of its specialty biotherapeutics to treat hemophilia A and/or von Willebrand Disease to the WFH Global Alliance for Progress (GAP) Program and other WFH programs. PDF


U.S. FDA Approves CSL Behring’s IDELVION® - The First and Only Hemophilia B Therapy with Up to 14-day Dosing Intervals
KING OF PRUSSIA, Pa. – March 4, 2016 – CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B. PDF


CSL Behring’s Long-acting rIX-FP for Hemophilia B - IDELVION® - Receives Positive Opinion from European Medicines Agency CHMP
MARBURG, Germany – February 29, 2016 – Global biotherapeutics leader CSL Behring announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for IDELVION® (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) for patients with hemophilia B. PDF

 

Updated September 2018