Nasal Sprays Containing Desmopressin Recalled Due to Superpotency
One nonfatal adverse event has been reported during the timeframe the affected product was distributed.
Diagnosis & Disease Information
FDA Approves Sevenfact for Hemophilia A or B With Inhibitors
The FDA has approved Sevenfact (coagulation factor VIIa [recombinant]-jncw; LFB Biotechnologies) for the treatment and control of bleeding episodes occurring in patients aged ≥12 years with hemophilia A or B with inhibitors.
New Drug Product: Esperoct
This slideshow shows drug information for Esperoct. Click here for the complete Esperoct monograph.
Gene Therapy for Hemophilia A Gets FDA’s Priority Review
The Agency also accepted the premarket approval (PMA) application for an AAV5 total antibody assay, a companion diagnostic test for valoctocogene roxaparvovec.
Esperoct Now Available for Treatment of Hemophilia A
Novo Nordisk announced the launch of Esperoct® (antihemophilic factor [recombinant], glycopegylated-exei) for the treatment of adult and pediatric patients with hemophilia A for routine prophylaxis.
BLA Submitted for Gene Therapy to Treat Hemophilia A
BioMarin has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for valoctocogene roxaparvovec (BMN 270) for the treatment of hemophilia A in adults. This is the first marketing application submission for a gene therapy product for any type of hemophilia. Valoctocogene roxaparvovec is an investigational adeno-associated virus (AAV) gene therapy…
Investigational Therapy for Hemophilia A Granted Orphan Drug Designation
The Food and Drug Administration (FDA) has granted Orphan Drug designation to SIG-001 (Sigilon Therapeutics) for the treatment of hemophilia A. SIG-001 utilizes Sigilon’s Shielded Living Therapeutics platform to implant engineered human cells to produce stable blood plasma levels of factor VIII. The cells are also shielded by Sigilon’s proprietary Afibromer biomaterials matrix that minimizes…
Esperoct Approval Provides New Treatment Option for Hemophilia A
Novo Nordisk announced that the Food and Drug Administration (FDA) has approved Esperoct (turoctocog alfa pegol, N8-GP) for the treatment of patients with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes and perioperative management of bleeding.
FDA Approves Expanded Indication for Hemlibra in Hemophilia A
The expanded approval was based on data from two Phase 3 clinical trials: HAVEN 3 and HAVEN 4.
Jivi With Step-Wise Dosing Approved for Management of Hemophilia A
The approval was supported by data from the phase 2/3 international, open-label PROTECT VIII trial (N=126) that evaluated previously treated patients aged ≥12 years with severe hemophilia A.
