The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s concizumab, which will be sold under the brand name Alhemo, as a daily treatment to prevent or reduce the frequency of bleeding episodes in certain adults and adolescents with hemophilia. Eligible patients are those with hemophilia…
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Brazilian hemophilia A patients who are 19 or older had significantly higher median care costs per patient per year than younger patients, a study reported. The study also revealed an increase in median costs for patients with more severe disease — that is, those who have less than 1%…
Recombinate (antihemophilic factor recombinant) was a recombinant (lab-made) clotting factor VIII (FVIII) concentrate that was approved to prevent and control bleeds, including those occurring during surgery, in children and adults with hemophilia A. It was administered via intravenous, or into-the-vein, injection.
FLT180a, also known as verbrinacogene setparvovec, is an investigational gene therapy that was investigated as a treatment for people with hemophilia B.
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for Afstyla (lonoctocog alfa) for the treatment and prevention of bleeding in adults and children with hemophilia A. Developed by CSL Behring, Afstyla is a single-chain recombinant human factor VIII…
The first patient has been dosed in China in a registrational clinical trial of BBM-H803, a one-time investigational gene therapy that Belief BioMed is developing to prevent bleeding in hemophilia A. The Phase 1/2/3 clinical trial (CTR20233400) is testing how safe and well tolerated BBM-H803 is as a…
A single dose of the experimental gene therapy SPK-8016 showed promising safety and efficacy in lowering the frequency of bleeds and the need for infusions in men with severe hemophilia A. These preliminary findings from an ongoing Phase 1/2 trial (NCT03734588) were presented by Spencer Sullivan, MD,…
Dr. Reddy’s Laboratories announced the U.S. launch of a generic version of DDAVP (desmopressin acetate), used to control bleeding in people with mild hemophilia A. The generic is available under the name Desmopressin Acetate Injection USP, 4 micrograms/mL, in a carton of 10 single-dose ampules…
Most children with hemophilia A given Altuviiio (efanesoctocog alfa) once a week were bleed-free throughout about a year of treatment. That’s according to top-line data from the Phase 3 XTEND-Kids trial (NCT04759131) announced by Sobi and Sanofi, the therapy’s co-developers, less than a month after…
A new five-year alliance between Bayer and the World Federation of Hemophilia (WFH) Humanitarian Aid Program will deliver training, education and treatments to healthcare professionals in more than 60 underserved countries. ”Three out of four people with bleeding disorders living in developing countries do not have access to…