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MASAC Issues Safety Information Update on Emicizumab (HEMLIBRA)

April 24, 2018

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) has released a safety information update about Emicizumab (Hemlibra), a new subcutaneous treatment for hemophilia A patients with inhibitors. This update has been released following the first report of an anti-drug antibody to Emicizumab. MASAC’s update issues recommendations for providers and patients in case of […]

Genentech Offers Hemlibra Update

March 28, 2018

Note: The following is an excerpt from a press release from Genentech. Read the full press release here. ______________________________________________________________________________________ Given the recent dialogue, we are reaching out to clarify the facts surrounding five people with hemophilia A with inhibitors to factor VIII who have passed away while receiving Hemlibra® (emicizumab-kxwh). Since 2016, five adults with hemophilia A […]

Genentech Provides Statement Regarding Patient Access to Hemlibra

January 11, 2018

Genentech has published a statement regarding patient access to Hemlibra (Emicizumab-kkwh). Read the full statement in its entirety here.  

FDA Approves Genentech’s HEMLIBRA, (Emicizumab-KXWH) for Hemophilia A with Inhibitors

November 16, 2017

Note: The following is an edited excerpt from a press release from Genentech. To read the press release in it’s entirety, click HERE. Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has approved HEMLIBRA® (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes […]

FDA Grants Priority Review to Genentech’s Emicizumab for Hemophilia A with Inhibitors

August 24, 2017

Note: The following is an edited version of a press release from Genentech. Read the press release from Genentech in it’s entirety here. Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for emicizumab prophylaxis (preventative) as […]

Infusing Love: Not What I Had Planned

July 12, 2017

I like control. I like order. I like a plan. I like lists. Not in an overly aggressive way, but in a way that makes me feel calm. If I can plan for it, I can feel in control of it. Hemophilia does not work this way. Hemophilia and all the moving parts involved with […]

Genentech Announces Positive Phase III Results for Emicizumab at ISTH 2017

July 10, 2017

Note: The following is an edited version of a press release from Genentech. Read the press release from Genentech in it’s entirety here. Genentech, a member of the Roche Group, announced today that data from HAVEN 1, a Phase III study evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) in adults and adolescents with hemophilia A with inhibitors, were published […]

Genentech Announces Results in Emicizumab Phase III Studies (HAVEN 1 And HAVEN 2) in Hemophilia A With Inhibitors

June 26, 2017

Genentech, a member of the Roche Group announced today positive data from the primary analysis of the Phase III HAVEN 1 study in adults and adolescents and interim analysis of the Phase III HAVEN 2 study in children evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) for the treatment of hemophilia A with inhibitors to factor VIII. […]

Infusing Love: Change of Plans

June 21, 2017

  It’s that time of year when boys and girls go to summer camp. Church camp, art camp, band camp, sports camp and yes, hemophilia camps. My idea of camping and “roughing it” is when we stay at a hotel that is not a “suite.” When my oldest son, Julian, was nearing the age of […]

Genentech Announces Interim Results from Phase III HAVEN 2 Study

April 17, 2017

On April 16, 2017 Genentech announced interim results from the Phase III HAVEN 2 study evaluating emicizumab prophylaxis in children less than 12 years of age with hemophilia A and inhibitors to factor VIII. According to this Genentech’s press releases, “interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful reduction in the […]

CDC Describes New Method to Detect Specific Antibodies in Inhibitor Development

January 24, 2017

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 […]

HEMA Biologics Receives FDA License for New Recombinant Factor VIIa Product

January 10, 2017

Note: The following is edited from a press release from PRNewswire.com. Read the full press release in it’s entirety here. HEMA Biologics, LLC announced that the FDA has accepted the Biologics License Application(BLA) for their first potential product for commercialization in the United States.  The acceptance of the BLA for Coagulation Factor VIIa, Recombinant (eptacog beta […]

Infusing Love: Smells and Sounds

January 4, 2017

The senses of sound and smell are very powerful. Sometimes a smell can spark a memory of a wonderful meal simmering on a stove or the smell of the air from a perfect breeze on a spring day can transport us back. The sounds of elevators dinging as people anxiously wait their turn and the sliding […]

Genentech Meets Primary Endpoint for Phase III Emicizumab Study

December 22, 2016

______________________________________________________________________________ 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 […]

Octapharma Presents Phase III NuProtect Data at 2016 ASH Annual Meeting

December 22, 2016

______________________________________________________________________________ Note: The following is edited from a press release from Octapharma. Read the full press release in it’s entirety here. At the recent American Society of Hematology (ASH) Annual Meeting, Octapharma presented interim data from the ongoing phase 3 study, NuProtect. The NuProtect Study examines the immunogenicity, efficacy and safety of treatment with human cell-line derived recombinant […]

Infusing Love: Stealing My Joy? Never!

October 19, 2016

  For over a year my family has lived like most everyone else in the world.  We get up, go to work and school, have fun, go on trips, eat and play….it’s all very good.  Our oldest son has gone away to college and our youngest is in the fifth grade. The blessing has been […]

Update #4: MASAC Issues Recommendation on SIPPET

June 28, 2016

On June 28, 2016, the National Hemophilia Foundation’s Medical and Scientific Advisory Committee (MASAC) issued a recommendation following the published results of the Survey of Inhibitors in Plasma Products Exposed Toddler (SIPPET) The SIPPET study was published in the New England Journal Of Medicine (NEJM) in May 2016. The full text of the SIPPET study is available for a […]

Update #3: SIPPET Study Released

June 14, 2016

On May 26 2016, the New England Journal Of Medicine (NEJM) published the results of the Survey of Inhibitors in Plasma Products Exposed Toddler (SIPPET) study. Investigators found that in a randomized study, when previously-untreated patients (PUPs) were treated with recombinant factor VIII, there was an 87% higher incidence of inhibitor development than when treated with plasma-derived factor VIII. […]

Emicizumab Study Results Released in New England Journal of Medicine

May 26, 2016

Note: The New England Journal of Medicine released an article outlining the results of a study of a new drug, Emicizumab (ACE910, Chugai Pharmaceuticals), that shows reduced bleeding in patients with severe hemophilia A. Read the full article, Factor VIII–Mimetic Function of Humanized Bispecific Antibody in Hemophilia A, in the New England Journal of Medicine. This video […]

Infusing Love: A Double Edged Sword

March 9, 2016

There are three words that I have a love-hate relationship with. The words are spoken with good intention and they aren’t fancy, SAT prep course worthy words. They are simple words, in a simple sentence, but there’s no simple answer to the question. “How’s Thomas doing?” It’s double-edged sword. It’s almost impossible for me to […]

Community Voices: An Inhibitor On The High Seas

February 16, 2016

Justin Levesque (pictured in the orange hat), poses with the crew aboard a ship bound for Iceland.  __________________________________________ Justin Levesque has severe hemophilia with an inhibitor. Justin recently had an opportunity of a lifetime when he spent nine days aboard a ship to Iceland as part of an art project that he developed. In this […]

Update #2: SIPPET Study

December 10, 2015

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). […]

Dear Addy: Inhibitors

November 23, 2015

Dear Addy, I’m taking my son in for his annual visit, and I saw that MASAC issued a statement about inhibitors. Should I have him checked for one? Signed, Learning All I Can Dear Learning, Inhibitors are antibodies that the immune system develops in response to a clotting factor product used to treat a person […]

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

November 14, 2015

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 […]

Infusing Love: Towards the Light or the Shadow?

July 8, 2015

When you are in the middle of what seems like a never-ending bleed, you function in the moment, hoping that things get better soon. Living with a chronic condition has helped my family learn to look at things in a positive light, and I like to think it has helped me become someone who sees […]

FDA Grants Orphan Status for New Inhibitor Treatment

July 2, 2015

Below is from a press release Apitope sent out on June 9, 2015. To read it in its entirety, click here. Apitope, the drug discovery and development company focused on disease-modifying treatments that reinstate immune tolerance, announced today that pre-clinical product candidate ATX-F8-117 has been granted Orphan Drug Status by the US Food and Drug […]

Infusing Love: Friends to the Rescue

June 18, 2015

We had a tough winter. We spent more time than ever before cuddled up in an ER room watching whatever Disney movie was on the in-hospital. Doctors and nurses would rush in and out. We ate fast food and hospital food.. We coped. Because, this is our life. This is our reality. We have a […]

How a Second Grader with Hemophilia Copes with Pain

June 9, 2015

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 […]

Infusing Love: Celebrations & A Heavy Heart

January 14, 2015

My son Caeleb has struggled with an inhibitor since he was 11 months old.  Despite many doctors’ recommendations, it’s never been as “simple” as waiting to get below a 10 Bethesda Unit measurement to start immune tolerance therapy (ITT).  He developed a rare allergy to Factor VIII and there is no known treatment or protocol […]

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 […]


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