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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Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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