Tag: Inhibitor Antibody

FDA Approves Genentech's Hemlibra

The following is an excerpt from a press release from Genentech. Read the entire press release here. Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved Hemlibra®(emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, […]

CDC Describes New Method to Detect Specific Antibodies in Inhibitor Development

Note: The following is an abridged form of an article from the Centers for Disease Control and Prevention(CDC). The original full-length of the article can be read here. The Centers for Disease Control and Prevention (CDC), along with researchers from the Hemophilia Inhibitor Research Study (HIRS), have recently published two articles in The Journal of Thrombosis and Haemostasis. The articles describe […]

Genentech Meets Primary Endpoint for Phase III Emicizumab Study

______________________________________________________________________________Note: The following is edited from a press release from Genentech. Read the full press release in it’s entirety here.Genentech, a member of the Roche Group, announced that the primary endpoint has been met for the Phase III HAVEN 1 study evaluating emicizumab prophylaxis in people 12 years of age or older with hemophilia A and […]

Update #2: SIPPET Study

This past weekend, the American Society of Hematology (ASH), a worldwide organization of 15,000+ medical and scientific experts on blood diseases, held their 57th Annual Meeting to discuss new treatments and research methods.During this meeting, a group of doctors from around the globe presented the findings of the Survey of Inhibitors in Plasma-Product Exposed Toddlers (SIPPET). The […]

UPDATE #1: Results of Toddler Inhibitor Study (SIPPET) Announced

The American Society of Hemophilia (ASH) released information about their upcoming 57th ASH Annual Meeting, which will be held December 5-8, 2015 in Orlando, Florida. Included in the program information is a paper abstract about the SIPPET study (Survey of Inhibitors in Plasma-Product Exposed Toddlers.) A plenary session with further information will be presented at the […]

How a Second Grader with Hemophilia Copes with Pain

Kelly and Brian of Oregon never expected their son, Bubba, to have severe hemophilia A, and they certainly never expected Bubba to experience the complications of an inhibitor and chronic pain in his childhood. Kelly shared her family’s experiences with HFA with hopes that other families can learn from their experiences. How did you find […]

Inhibitor Patients Have Increased Risk for Joint Disease & Other Complications

Note: The below email was sent by the Centers Disease Control and Prevention (CDC) on April 3, 2015: People with hemophilia lack a protein (a clotting factor) necessary for blood to clot normally. This can lead to spontaneous bleeding as well as bleeding following injuries or surgery. The best way to treat hemophilia is to replace the […]

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

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 statement […]

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

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 abstract of this study.*Note: Unfortunately, […]

An Inhibitor Mom Shares Her Story With the FDA

On Monday, September 22, several members of the bleeding disorders community came out to share their experiences with bleeding disorders treatment with the FDA.HFA worked with partners like NORD, PPTA, and NHF to ensure that our community was effectively represented. Patients and advocates of every age, every background, and with several different conditions came out to […]