CSL’s Hemgenix (etranacogene dezaparvovec-drlb) Receives the US FDA’s Approval for the Treatment of Hemophilia B
Shots:
- The US FDA has approved Hemgenix (etranacogene dezaparvovec-drlb) for the treatment of adult patients with hemophilia B
- The approval was based on an ongoing P-III trial (HOPE-B) evaluating the safety & efficacy of Hemgenix in 54 adult patients with hemophilia B. The results showed mean factor IX activity of 39% @6mos. and 36.7% @24mos. post-infusion, 54% reduction in mean adjusted ABR for all bleeds @6-18mos. post-infusion over 6mos. lead-in period on factor IX prophylactic replacement therapy (4.1 to 1.9)
- 94% of patients discontinued the use of prophylaxis & remained free of previous continuous routine prophylaxis therapy, no serious adverse reactions were reported with no inhibitors to factor IX
Ref:- CSL | Image: CSL
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