Koāte (human antihemophilic factor) is a plasma-derived factor replacement therapy approved to prevent and control bleeding episodes or help manage bleeds during surgery in people with hemophilia A.
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Three patients who received SPK-8011 — a gene therapy developed by Spark Therapeutics — for hemophilia A show increased production of clotting factor VIII without any safety issues reported, says the company. The patients are the first to receive the treatment as part of a Phase 1/2 clinical trial, with…
Novo Nordisk is inviting children and young adults with hemophilia A and B to take part in its observational study of how this disease affects brain development, thinking, and behavior. Results will help researchers better understand how advances in hemophilia treatment, like routine prophylaxis, impact the brain by establishing…
The U.S. Food and Drug Administration (FDA) has pushed back by more than one year a decision on Roctavian, the potential first gene therapy for adults with hemophilia A. In a complete response letter that took the therapy’s developer, BioMarin by surprise, the FDA said it needed…
The U.S. Food and Drug Administration (FDA) has approved Expression Therapeutics‘ request to open a Phase 1 trial of ET3, an investigational gene therapy for people with hemophilia A. The decision followed a review of the company’s investigational new drug application (IND) requesting clearance of ET3…
Shire Korea recently received approval from South Korea’s Ministry of Food and Drug Safety for Adynovate (BAX 855), a long-lasting factor VIII gene recombinant therapy for hemophilia A. Adynovate is an injectable form of Shire’s Advate, which is Korea’s most commonly used treatment for the blood disorder. Shire Korea…
Men in South America with severe hemophilia A or B are hit with both direct and indirect costs related to the genetic disease, which also affect quality of life, a new study reports. As much as 99% of the direct costs of hemophilia were related to factor…
Most young people with moderate or severe hemophilia A and B in France receive long-term prophylactic (preventive) treatment — an approach linked to a lower rate of bleeding episodes than among patients treated on demand. The study, “Choice of factor VIII/IX regimen in adolescents and young adults with…
Canadian Blood Services (CBS) has awarded a three-year tender — an exclusive bulk purchase agreement aiming to minimize medication cost — to Takeda Canada for the purchase of Adynovate, an injectable replacement therapy for the prevention and treatment of bleeding episodes in people with hemophilia A. This…
The spleen’s marginal zone (MZ) B-cells respond to blood coagulation factor VIII (FVIII) and show potential to become the target of future therapies to reduce FVIII inhibitors in hemophilia A, according to new research in mice. The study, “Marginal zone B cells are critical to factor VIII inhibitor…