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Bayer Letter on Product Availability During COVID-19

April 9, 2020

The following is a copy of a letter from Bayer. “For more than 30 years, Bayer has been providing FVIII therapies and support programs to people living with hemophilia A. As we all face the current coronavirus (COVID-19) outbreak, the health and safety of our patients continues to be a priority. We realize you may […]

Bayer Statement on Availability of Factor VIII Products Amid 2019-nCoV (Novel Coronavirus)

March 5, 2020

Bayer has issued the following statement regarding the supply and availability of Bayer’s Factor VIII/Hemophilia A products in the wake of the¬†2019-nCoV (novel coronavirus) outbreak:

HFA & NHF Discuss Bayer Recall with FDA

October 7, 2019

HFA and NHF are pleased to share a brief update with the community concerning a recent meeting we had with the FDA as well as a number of additional resources that the FDA provided after the call.¬† HFA and NHF will continue to update the bleeding disorders community as any further information develops. Please note […]

Joint Statement #5 on Recall of Bayer Kogenate¬ģ FS Lots

September 23, 2019

Bayer announced the recall of two lots of Kogenate¬ģ¬†FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply […]

Joint Statement #4 on Recall of Bayer Kogenate¬ģ FS Lots

August 22, 2019

Hemophilia Federation of America and National Hemophilia Foundation continue to follow up on issues arising from Bayer‚Äôs distribution of mislabeled, expired clotting factor and subsequent recall of that product. The most recent set of joint HFA-NHF inquiries to Bayer focused on the short- and long-term medical consequences for affected patients. Bayer today released this response […]

Washington Wire: July 2019

July 31, 2019

FEATURED STORIES Product recall announced; patient organizations are in ongoing communications with manufacturer Bayer announced the recall of two lots of Kogenate¬ģ¬†FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate […]

Joint Statement #2 on Recall of Bayer Kogenate¬ģ FS Lots

July 31, 2019

Bayer announced the recall of two lots of Kogenate¬ģ¬†FS antihemophilic factor (recombinant) 2000 I.U. vials on July 19, 2019. Bayer announced that 3000 I.U. of one product (Jivi), past its expiration date, had been mislabeled as another product (2000 I.U. of Kogenate FS) and distributed to the public for six months. This is a deeply […]

Joint Statement on Recall of Bayer Kogenate¬ģ¬†FS Lots

July 26, 2019

Last week, Bayer announced the recall of two lots of Kogenate¬ģ¬†FS antihemophilic factor (recombinant) 2000 IU vials.That highly concerning announcement has raised many questions on the part of both national organizations and community members. The fact that one product (Jivi), past its expiration date, was mislabeled as another product (Kogenate FS) and distributed to the […]

RECALL NOTICE: Bayer Voluntarily Recalling Factor 8 Product

July 19, 2019

The following is a press release from Bayer regarding a voluntary recall. PATIENTS SHOULD NOT USE THIS PRODUCT! Bayer is voluntarily recalling two lots of Kogenate¬ģ FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain […]

Bayer to present new data at Congress of International Society on Thrombosis and Haemostasis

June 27, 2019

The following is an excerpt of a press release from Bayer. Read the press release in its entirety here. Bayer will present new data highlighting clinical outcomes from its hemophilia A portfolio, which include long-term data from the PROTECT VIII investigational study evaluating use of Jivi¬ģ antihemophilic factor (recombinant) PEGylated-aucl. These data will be presented […]

Bayer Receives FDA Approval for Jivi, New Hemophilia A Treatment With Step-Wise Prophylaxis Dosing Regimen

August 31, 2018

The following is an excerpt from a press release from Bayer. Read the press release in its entirety here.¬† Bayer announced that the U.S. Food and Drug Administration has approved Jivi¬ģ for the routine prophylactic treatment of hemophilia A in previously-treated adults and adolescents 12 years of age or older. The initial recommended prophylactic regimen […]

Bayer Issues Voluntary Recall of Kogenate FS

October 18, 2017

Note: The following is the full text of an email communication received by HFA from Bayer HealthCare Pharmaceuticals: Bayer in consultation with the FDA has voluntarily recalled approximately 300 vials (part of one lot) of Kogenate¬ģ FS, Antihemophilic Factor (Recombinant) in the U.S. as¬†an excipient, used to stabilize the product during manufacturing, may not conform […]

Prescription Benefit Program Changes for Recombinant Clotting Factor Product

October 18, 2016

  It has come to our attention that Helixate FS, a recombinant clotting factor product sold and distributed by CSL Behring, is being removed from prescription benefit programs for a limited number of¬†patients using CVS/Caremark effective January 1, 2017. Patients currently using Helixate FS who have the “Advanced Control Formulary” plan with¬†CVS/Caremark will have the […]

FDA Approves New Recombinant Factor Following LEOPOLD Trials

March 17, 2016

Note: The following is an edited version of a press release from Bayer. The original press release can be found here.¬† The U.S. Food and Drug Administration (FDA) has approved Bayer‚Äôs KOVALTRY¬ģ Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based […]

Update #3: NHF’s MASAC Assessment on Inhibitor Studies

December 3, 2014

On September 24, 2014, the medical journal,¬†Blood, came out with a study called,¬†Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.¬† This study suggests¬†that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using¬†Kogenate/Helixate.¬† The¬†World Hemophilia Federation¬†(WHF) issued a¬†statement on October 6,¬†and another […]

Update #2: FDA will Review Study Suggesting Higher Inhibitor Incidence in PUPS

November 20, 2014

On September 24, 2014, the medical journal,¬†Blood, came out with a study called,¬†Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.¬† This study suggests¬†that inhibitor incidence is higher in previously untreated patients (PUPs) with severe hemophilia A that are using¬†Kogenate/Helixate. The Food and Drug Administration¬†(FDA)¬†and European Medicines Agency (EMA)¬†have […]

Update #1: Study Suggests Higher Inhibitor Incidence in PUPS Using Kogenate/Helixate

October 6, 2014

On September 24, 2014, the medical journal, Blood, came out with a study called, Recombinant Factor VIII Products and Inhibitor Development in Previously Untreated Boys with Severe Hemophilia A.¬† This study suggests¬†that inhibitor incidence is higher in previously untreated patients (PUPs) with severe Hemophilia A that are using Kogenate/Helixate (Bayer/Nexgen). Click here to read the […]

Bayer to Develop Hemophilia Gene Therapy Treatment

June 23, 2014

Dimension Therapeutics, a Cambridge biotechnology startup, has struck a deal worth up to $252 million with the pharmaceutical giant Bayer HealthCare to develop a gene therapy to treat hemophilia, a rare disease that prevents blood from clotting. The goal of the prospective treatment, which is not yet in clinical trials, is to repair a faulty […]

Bayer Hemophilia Awards Program (BHAP) Recipients

May 19, 2014

Harvard Stem Cell Institute Affiliated Faculty member Juan Melero-Martin, PhD, at Boston Children’s Hospital is one of the 2014 grant recipients of the Bayer Hemophilia Awards Program (BHAP), a unique initiative dedicated to supporting innovative research and educational initiatives that benefit people with hemophilia. This year, Bayer Healthcare awarded more than $2 million in funding […]

FDA Approves Bayer’s Kogenate¬ģ FS for Adult Prophylaxis

May 13, 2014

Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer’s Kogenate¬ģ FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. The approval is based on data from the SPINART study, in which 84 patients […]


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