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Hemophilia News

FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors

Posted 2 days 12 hours ago by Drugs.com

November 16, 2017 – The U.S. Food and Drug Administration today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. “Reducing the frequency or preventing bleeding episodes is an important part of disease management for patients with hemophilia. Today’s approval provides a new preventative treatment that has been shown to significantly reduce the number of bleeding episodes in patients with hemophilia A with Factor VIII inhibitors,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “In addition, patients treated with Hemlibra reported an improvement in their physical functioning.” ... Read more

Related support groups: Hemophilia, Hemophilia A, Hemophilia A with Inhibitors, Emicizumab, Hemlibra

Is Blood Donated by Mothers Less Safe for Men?

Posted 17 Oct 2017 by Drugs.com

TUESDAY, Oct. 17, 2017 – Men who receive blood donated by previously pregnant women may face an increased risk of death following the transfusion, a new study from the Netherlands suggests. Males transfused with blood from a woman with a history of pregnancy appear to be 13 percent overall more likely to die in coming years, compared with those who received blood from another man, said researchers from Sanquin, the Dutch national blood bank. The highest risk seemed to be in men 18 to 50 years old. They had a 50 percent increased risk of death after receiving blood from a previously pregnant female, said Sanquin spokesman Merlijn van Hasselt, who answered questions on behalf of the research team. "The risk remained increased for many years after transfusion. No such increase was observed for female recipients, or for male recipients over 50 years," van Hasselt said. Pregnancy might ... Read more

Related support groups: Blood Transfusion, von Willebrand's Disease, Hemophilia, Coagulation Defects and Disorders, Bleeding Associated with Coagulation Defect, Labor and Delivery including Augmentation, Hemophilia B, Hemophilia A, Blood Cell Transplantation

First Test to Detect Zika in Blood Donations Approved

Posted 7 Oct 2017 by Drugs.com

FRIDAY, Oct. 6, 2017 – The cobas Zika test has been approved by the U.S. Food and Drug Administration – the first approved screening test to detect the Zika virus in blood donations. The test is not designed to diagnose any particular person's Zika infection, however, the FDA said. In August 2016, the agency recommended that all U.S. states and territories screen blood for Zika, according to an FDA media release. "Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. Some blood-collection centers had already been using the cobas test in order to comply with the 2016 edict. Data collected from this testing, in tandem with additional information provided by the test's manufacturer, were used to approve the diagnostic, the FDA ... Read more

Related support groups: Blood Transfusion, Insect Bites, von Willebrand's Disease, Coagulation Defects and Disorders, Hemophilia, Zika Virus Infection, Blood Cell Transplantation

Health Tip: Giving Blood

Posted 4 Oct 2017 by Drugs.com

-- Donating blood for the first time may sound intimidating. But the process is fairly painless, takes only about 20 minutes and could help save a life. The American Red Cross explains the different types of blood donation: Whole blood – The most common and quickest type of donation, involving a pint of whole blood. The donation is typically separated into transfusable components, including red cells, plasma and platelets. Red cells – Red blood cells are the most frequently transfused part of blood. In this type of collection, only the red blood cells are collected and most of the platelets and plasma are returned to the donor. Platelet – Platelet donations take longer than whole-blood donations. During this procedure, an apheresis machine collects platelets and returns red cells and the majority of the plasma back to the donor. Platelets are an important part of some cancer ... Read more

Related support groups: Blood Disorders, Bleeding Disorder, Anemia, Blood Transfusion, von Willebrand's Disease, Hemophilia, Anemia Associated with Chronic Disease, Blood Cell Transplantation

FDA Approves Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for Patients with Hemophilia B

Posted 27 Jun 2017 by Drugs.com

PLAINSBORO, N.J., May 31, 2017 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for Rebinyn (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B. Hemophilia B is a chronic and inherited bleeding disorder that affects approximately 5,000 people in the U.S.1 People with hemophilia B have deficient blood clotting factor IX activity that results in prolonged or spontaneous bleeding, especially into the muscles, joints or internal organs.2 Rebinyn® is the brand name for nonacog beta pegol, N9-GP. Rebinyn® is indicated for on-demand treatment and control of bleeding episodes, and the perioperative management of bleeding in adults and children with hemophilia B. Rebinyn® is not indicated for routine prophylaxis or for immune tolerance in ... Read more

Related support groups: Hemophilia, Coagulation Defects and Disorders, Hemophilia B, Coagulation Factor Ix, Rebinyn, Coagulation Modifiers

FDA OKs 1st At-Home Genetic Tests for 10 Disorders

Posted 6 Apr 2017 by Drugs.com

THURSDAY, April 6, 2017 – The U.S. Food and Drug Administration has approved the first home genetic tests for 10 health risks, including Parkinson's disease and late-onset Alzheimer's. The approval – granted to the California-based company 23andMe Inc. – could help test users make lifestyle choices or spark important discussions with health care providers, the FDA said. "Consumers can now have direct access to certain genetic risk information," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said Thursday in an agency news release. "But, it is important that people understand that genetic risk is just one piece of the bigger puzzle. It does not mean they will or won't ultimately develop a disease," he added. Along with genetics, many things can contribute to disease and illness, including lifestyle and environmental factors, the FDA said. The ... Read more

Related support groups: Parkinson's Disease, Alzheimer's Disease, Celiac Disease, Parkinsonism, Diagnosis and Investigation, Hemophilia, Gaucher Disease

Gene Therapy Offers Hope to Some Hemophilia Patients

Posted 6 Dec 2016 by Drugs.com

TUESDAY, Dec. 6, 2016 – Preliminary research suggests that a single dose of an experimental gene therapy may help patients with hemophilia B. As explained by the National Hemophilia Foundation, hemophilia B is a genetic disorder where people lack a protein needed for blood clotting called factor IX, or that the type of factor IX they produce is defective. The condition can lead to excess bleeding and occurs in about one in every 5,000 births, the foundation said. But researchers said they've never seen a medical treatment boost factor IX to the level seen in the new trial. According to the findings, patients who got the gene therapy were able to stop getting infusions of the clotting factor. "Our goal in this trial was to evaluate the safety of the gene therapy product and secondarily, to determine if we could achieve levels of factor IX that could decrease bleeding events in ... Read more

Related support groups: Blood Disorders, Bleeding Disorder, Hemophilia, Hemophilia B

Two New Findings Offer Hope for Those With Severe Hemophilia

Posted 26 May 2016 by Drugs.com

WEDNESDAY, May 25, 2016 – Two new studies could pave the way to major changes in how doctors treat severe cases of hemophilia – a rare genetic disorder that can cause uncontrolled bleeding. Both studies tackle a key challenge: Up to one-third of children with severe hemophilia develop antibodies against the standard therapy. But one study highlights the value of an old therapy, while the other shows promising early results with an experimental drug. Experts said both should stir discussion among doctors, patients and parents who deal with hemophilia. But they were especially hopeful about the new drug, known as emicizumab. In the United States, about 20,000 people – mostly boys and men – are living with hemophilia, according to the U.S. Centers for Disease Control and Prevention. The disorder is caused by a defect in one of the genes that controls proteins needed for normal blood ... Read more

Related support groups: Blood Disorders, Bleeding Disorder, Anemia, Blood Transfusion, Hemophilia, Coagulation Defects and Disorders, Hemophilia B, Hemophilia A, Blood Cell Transplantation, Hemophilia A with Inhibitors

Review Finds Mixed Success With Hemophilia Treatment

Posted 16 Mar 2016 by Drugs.com

WEDNESDAY, March 16, 2016 – Though the past 50 years have brought major treatment advances, men with severe hemophilia are still at high risk for bleeding and physical disability, experts say. Hemophilia is a genetic disease that prevents blood from clotting normally, leading to an increased risk of serious bleeding. More common in men than in women, it affects about one out of every 5,000 men, according to the U.S. Centers for Disease Control and Prevention. Researchers analyzed data from nearly 7,500 male hemophilia patients in the United States between 1998 and 2011. Their findings were published online March 16 in the journal Blood. "Our analysis provides a snapshot of how improvements in care have translated into outcomes across different generations of men with hemophilia," study author Dr. Paul Monahan said in a journal news release. Monahan is a former professor of hematology ... Read more

Related support groups: Blood Disorders, Bleeding Disorder, Hemophilia, Coagulation Defects and Disorders, Hemophilia B, Hemophilia A, Hemophilia A with Inhibitors

FDA Approves Nuwiq (Antihemophilic Factor [Recombinant]) for Hemophilia A

Posted 17 Sep 2015 by Drugs.com

HOBOKEN, N.J. September 15th, 2015: Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Nuwiq, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The Nuwiq approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding. Nuwiq is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of patients with Hemophilia A, congenital FVIII deficiency. Hemophilia A impacts the lives of up to 16,000 individuals in the U.S. and their caregivers. Although present therapies for Hemophilia A treatment exist in the U.S., significant challenges still remain, including development ... Read more

Related support groups: Hemophilia, Antihemophilic Factor, Hemophilia A, Nuwiq

Kids' Hemophilia Drugs a Big Part of State Medicaid Spending

Posted 31 Jul 2015 by Drugs.com

FRIDAY, July 31, 2015 – Treatment costs for one childhood illness, hemophilia, may use up a big chunk of a state's Medicaid budget, a new study out of California shows. The researchers found that treatments for hemophilia – a rare, inherited disorder in which blood does not clot normally – accounted for the largest share of spending on outpatient drugs among publicly insured children in California with serious chronic illnesses. The study "underscores the potential effect of new, expensive but [effective] pharmaceuticals on public insurance programs for children with chronic illness," wrote a group led by Sonja Swenson of Stanford University. Her team published the findings July 28 in the Journal of the American Medical Association. The researchers tracked 2010-2012 data from more than 34,300 publicly insured children and young adults under the age of 21 in California with serious ... Read more

Related support groups: Hemophilia, Antihemophilic Factor, Humate-P, Hemophilia A, Advate, Hemophilia B, Liberate, Factane, Hyate:C, Xyntha, Monoclate, Eloctate, Genarc, Koate-HP, Advate rAHF-PFM, Helixate, Optivate, Kogenate Bayer, Hemophilia A with Inhibitors, Beriate P

FDA Approves Obizur [Antihemophilic Factor (Recombinant)] for Acquired Hemophilia A

Posted 27 Oct 2014 by Drugs.com

DEERFIELD, Ill., October 24, 2014 - Baxter International Inc. today announced that the United States Food and Drug Administration (FDA) has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder. Obizur was granted orphan-drug status by the FDA and its review was prioritized based on AHA's classification as a rare disease and the potential for the treatment to address an important unmet medical need. Obizur is the first recombinant porcine FVIII treatment approved for AHA that allows physicians to manage the treatment's efficacy and safety by measuring factor VIII activity levels in addition to clinical assessments. Obizur replaces the inhibited human factor VIII with a recombinant porcine sequence factor VIII based on ... Read more

Related support groups: Hemophilia, Antihemophilic Factor, Hemophilia A

New Treatment Obizur Approved for Rare Form of Hemophilia

Posted 24 Oct 2014 by Drugs.com

FRIDAY, Oct. 24, 2014 – Obizur (antihemophilic factor recombinant) has been approved to treat a rare, non-inherited form of hemophilia in adults. Unlike the more common form of hemophilia that's inherited and affects males, acquired hemophilia affects both males and females. The rarer form of the blood disorder occurs when the body's immune system attacks a protein that's necessary for normal blood clotting. About half the cases of acquired hemophilia are related to other medical conditions, such as pregnancy, cancer or use of certain medications. But about half of cases have no known cause, the FDA said Friday in a news release. Obizur was evaluated in clinical studies involving 29 adults with acquired hemophilia, who were given Obizur to treat a serious bleeding episode. The trial didn't identify any safety concerns, the FDA said. Obizur is manufactured by Baxter Healthcare, based in ... Read more

Related support groups: Hemophilia

'Female' X Chromosome May Play Part in Sperm Production

Posted 22 Jul 2013 by Drugs.com

SUNDAY, July 21 – Researchers have made the surprising finding that the "female" X chromosome may have an important function in sperm production. Women have two X chromosomes and men have an X and Y chromosome. This study found that large portions of the X chromosome have evolved to play a specialized role in producing sperm. And despite its reputation as the most stable chromosome of the genome, the X chromosome has actually been undergoing relatively rapid changes, according to the study published online July 21 in the journal Nature Genetics. Taken together, these two findings suggest that it's time to reexamine the biological and medical importance of the X chromosome, said the researchers at the Whitehead Institute for Biomedical Research in Cambridge, Mass. "We view this as the double life of the X chromosome," Whitehead director David Page said in an institute news release. "The ... Read more

Related support groups: Oligospermia, Hemophilia, Color Vision Defect (Acquired)

FDA Approves Rixubis - First Recombinant Coagulation Factor IX For Use in Preventing Bleeding Episodes

Posted 27 Jun 2013 by Drugs.com

June 27, 2013 – The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, perioperative (period extending from the time of hospitalization for surgery to the time of discharge) management, and routine use to prevent or reduce the frequency of bleeding episodes (prophylaxis). An inherited blood clotting disorder mainly affecting males, Hemophilia B is caused by mutations in the Factor IX gene and leads to deficiency of Factor IX. Hemophilia B affects about 3,300 people in the United States. Individuals with Hemophilia B can experience potentially serious bleeding, mainly into the joints, which can be destroyed by such bleeding. “As the first recombinant coagulation factor IX indicated s ... Read more

Related support groups: Hemophilia, Coagulation Defects and Disorders, Hemophilia B, Coagulation Factor Ix

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Hemophilia A, Hemophilia B, Coagulation Defects and Disorders