Roche’s Hemlibra Receives the US FDA Approval for Haemophilia A Without Factor VIII Inhibitors

 Roche’s Hemlibra Receives the US FDA Approval for Haemophilia A Without Factor VIII Inhibitors

Roche’s Hemlibra Receives the US FDA Approval for Haemophilia A Without Factor VIII Inhibitors

Shots:

  • Hemlibra’s approval is based on results of P-III HAVEN 3 study assessing Hemlibra qw or q2w vs no prophylaxis and HAVEN 4 study assessing Hemlibra q4w, in patients aged ≥12 yrs. for safety, efficacy and PK
  • P-III HAVEN 3 (qw &q2w) & HAVEN 4 results: Reduction in treated bleeds (96% &97%): Reduction in treated target joint bleeds (95% &95%): Reduction in all bleeds (95% &94%); zero treated bleeds & 90.2% experienced three or four treated bleeds
  • Hemlibra (emicizumab) IV is a bispecific factor IXa- and factor X-directed Ab, with recommended dose qw, q2w or q4w. In 2017, Hemlibra received the US FDA approval to treat haemophilia A with factor VIII inhibitors in adults and children and also received the US FDA BT & PR designation

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

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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