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Hemophilia A News

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

Posted 20 Nov 2017 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 h ...

New Hemophilia A Treatment, Hemlibra (Emicizumab-kxwh), Stems Bleeding Episodes

Posted 16 Nov 2017 by Drugs.com

THURSDAY, Nov. 16, 2017 – Hemlibra (emicizumab-kxwh) has been approved by the U.S. Food and Drug Administration to prevent or reduce the number of bleeding episodes among certain people with hemophilia A. The injected drug was approved for patients with antibodies called Factor VIII inhibitors. People with hemophilia A are missing a gene that produces Factor VIII, a blood-clotting protein. ...

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 Develop Potential Oral Treatment for Hemophilia

Posted 30 Dec 2016 by Drugs.com

THURSDAY, Dec. 29, 2016 – People with hemophilia have to endure painful injections every few days to stay alive, but a newly developed treatment may one day offer a simpler, cheaper and less painful alternative. University of Texas at Austin researchers created an oral treatment for one type of hemophilia, which is a serious, genetic bleeding disorder. But, the treatment is still in the early ...

Shire Announces FDA Approval of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for Use in Children and Surgical Settings

Posted 29 Dec 2016 by Drugs.com

Lexington, Mass. – December 27, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Adynovate [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved Adynovate for use in sur ...

FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A

Posted 8 Jun 2016 by Drugs.com

KING OF PRUSSIA, Pa. — 26 May 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. Afstyla is the first and only single-chain product for hemophilia A that is specifically designed f ...

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 ...

FDA Approves Bayer's Kovaltry (Antihemophilic Factor (Recombinant)) for the Treatment of Children and Adults with Hemophilia A

Posted 18 Mar 2016 by Drugs.com

WHIPPANY, N.J., March 17, 2016 /PRNewswire/ – The U.S. Food and Drug Administration has approved Bayer's Kovaltry Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. The approval is based on results from the LEOPOLD (Long-Term Efficacy Open-Label Program in Severe Hemophilia A Disease) clinical trials, ...

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, ...

FDA Approves Adynovate Modified Antihemophilic Factor for Hemophilia A

Posted 16 Nov 2015 by Drugs.com

November 13, 2015 – The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A. Adynovate is modified to last longer in the blood and potentially require less frequent injections than unmodified Antihemophilic Factor when used to reduce the frequency of bleeding. ...

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 ...

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 ...

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 ...

FDA Approves Eloctate - first Antihemophilic Factor, Fc Fusion Protein for Patients with Hemophilia A

Posted 9 Jun 2014 by Drugs.com

June 6, 2014 – The U.S. Food and Drug Administration today approved Eloctate, Antihemophilic Factor (Recombinant), Fc fusion protein, for use in adults and children who have Hemophilia A. Eloctate is the first Hemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. Eloctate is approved to help control and prevent bleeding ...

New Hemophilia Remedy Eloctate Offers Potential for Fewer Injections

Posted 9 Jun 2014 by Drugs.com

MONDAY, June 9, 2014 – Eloctate, Antihemophilic Factor Fc Fusion has been approved by the U.S. Food and Drug Administration for people with Hemophilia A. It's designed to require less frequent injections than standard therapies used to reduce the frequency of bleeding episodes in people with the disorder, the FDA said in a news release. Hemophilia A is an inherited bleeding disorder that affects ...

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Hemophilia A with Inhibitors, Hemophilia

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tranexamic acid, desmopressin, DDAVP, Cyklokapron, anti-inhibitor coagulant complex, antihemophilic factor, Humate-P, Advate, Stimate, view more... Eloctate, Helixate, Koate-DVI, Kovaltry, Monarc-M, Koate-HP, Kogenate, Bioclate, Helixate FS, Hemofil-M, Obizur, Kogenate FS with Bioset, Xyntha, NovoSeven RT, Monoclate, NovoEight, Adynovate, Nuwiq, Biostate, Kogenate Bayer, Factane, Optivate, antihemophilic factor / von willebrand factor, coagulation factor viia, Genarc, Kogenate FS, Feiba VH Immuno, Autoplex T, Wilstart, Haemate P, Alphanate, Hyate:C, Beriate P, Fanhdi, Monoclate-P, Replenate, Liberate, ReFacto, Helixate NexGen, Recombinate, Afstyla