Small vesicles in the saliva of people with severe hemophilia A may explain why these patients rarely have bleeds in their mouth and throat. The vesicles contain a protein complex that’s able to induce blood coagulation in these patients, thereby reducing bleeding. The findings may help “develop innovative approaches…
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The U.S. Food and Drug administration (FDA) has approved Genentech’s Hemlibra (emicizumab-kxwh) for routine prophylactic (preventive) treatment of patients with hemophilia A without factor VIII inhibitors. Hemlibra is now the sole available prophylactic treatment for patients with hemophilia A with and without factor VIII inhibitors that can…
The U.S. Food and Drug Administration (FDA) has approved Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or lessen bleeding episodes in children and adults with hemophilia A with factor VIII inhibitors, Genentech announced. Hemlibra is first newly approved treatment for this patient group in almost 20 years, the…
The U.S. Food and Drug Administration (FDA) has given orphan drug and rare pediatric disease designations to Sernova’s experimental and cell-based hemophilia A treatment program using the Cell Pouch System, the company’s novel medical device. Orphan drug status is awarded to therapies aiming to treat…
Refixia or Rebinyn (nonacog beta pegol, or N9-GP), an approved replacement therapy for hemophilia B, is effective and has a good safety profile in previously untreated boys younger than 6 with severe to moderately severe disease, an early analysis of a Phase 3 trial indicates. In…
Prophylactic (preventive) treatment with Adynovate safely and effectively lowers the number of bleedings, including those in target joints, in children and adults with severe hemophilia A, according to data from two Phase 3 clinical trials. Notably, personalized Adynovate treatment targeting higher minimum blood levels of factor VIII (FVIII) —…
People with hemophilia are nearly four times more likely to experience sexual problems than are individuals without bleeding disorders, according to the results of a new international survey. The survey found that problems with sexual intimacy in patients with hemophilia were associated with older age, experiencing acute or chronic pain…
The risk of spontaneous bleeding episodes in patients with severe hemophilia A receiving preventive treatment changes over time and can be influenced by treatment history and other patient-related factors, a study has found. As such, the choice of an individual preventive — or prophylactic — regimen should take…
The U.S. Food and Drug Administration (FDA) has agreed to review Medexus Pharmaceuticals’ request to approve Ixinity (trenonacog alfa) for children with hemophilia B younger than 12. Ixinity is already approved by the FDA for adults and adolescents 12 and older. The therapy is indicated for use…
AscellaHealth and Audaire Health together are offering on a hemophilia management program that aims to containing prescription costs and help patients better manage their treatment needs. The program leverages AscellaHealth’s network of specialty pharmacy partners and Audaire’s healthcare technology to offer pharmacy network design, therapy utilization management, and clinical…