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
Ref: Roche | Image: Roche
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