Roche’s Hemlibra Receives FDA’s Breakthrough Therapy Designation for Hemophilia A without Factor VIII Inhibitors

 Roche’s Hemlibra Receives FDA’s Breakthrough Therapy Designation for Hemophilia A without Factor VIII Inhibitors

Roche’s Ventana PD-L1 (SP142) Receives FDA’s Approval for Identifying Triple-Negative Breast Cancer (TNBC) as CDx

Shots:

  • The FDA’s BT designation is based on P-III HAVEN 3 study assessing Hemlibra vs no prophylaxis in 152 patients in ratio (2:2:1) with hemophilia A + prior treated with factor VIII therapy aged>12years
  • The P-III HAVEN 3 study results: reduction in treated bleeds; superior to prior factor VIII prophylaxis; no thrombotic microangiopathy; no new safety signals observed
  • Hemlibra (emicizumab) IV is a bispecific factor IXa- and factor X-directed Ab, with recommended dose qw, q2w, developed by Chugai and co-developed by Roche and Genentech. In 2017, Hemlibra received the US FDA approval to treat hemophilia A with factor VIII inhibitors in adults and children

Click here to read full press release/ article | Ref: Roche | Image: Twitter

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