Larger Vial Size Approved for Hemophilia B Treatment Idelvion
The new 3500 IU vial size will help shorten the reconstitution time needed to prepare multiple vials for a similar dose.
Diagnosis & Disease Information
BLA for Extended Half-Life Factor VIII Hemophilia A Tx Filed With FDA
N8-GP (turoctocog alfa pegol) is a glycopegylated form of turoctocog alfa designed for prolonged half-life.
Rebinyn Now Available for the Treatment of Hemophilia B
Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate with an extended half-life, was approved by the Food and Drug Administration (FDA) in May 2017.
Hemophilic Arthropathy Treatment Gets Orphan Drug Designation
TRM-201 (rofecoxib) is a highly potent COX-2 selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile.
Rebinyn Approved to Treat Hemophilia B
Rebinyn, a recombinant DNA-derived coagulation Factor IX concentrate, temporarily replaces the missing coagulation Factor IX in hemophilia B patients.
Investigational Hemophilia B Gene Therapy Granted Breakthrough Status
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational gene therapy, AMT-060 (uniQure), for the treatment of severe hemophilia B.
Hemophilia A Treatment Gains Expanded Approval
Adynovate, an extended circulating half-life recombinant Factor VIII (rFVIII), was initially approved for use in patients aged ≥12 years with hemophilia A for on-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes.
Emicizumab Prophylaxis Reduced Number of Bleeds in Hemophilia A Trial
The primary endpoint was the number of bleeds over time among patients with emicizumab prophylaxis or no prophylaxis.
